Medicine

Today, a brief rundown of news involving Pfizer and Sarepta Therapeutics, as well as updates from UroGen Pharma, Altos Labs and BioNTech that you may have missed. A Food and…

Novo Nordisk is ramping up its war on compounders making versions of its top-selling semaglutide medicine as the regulatory grace period for their products officially ends. The Danish drugmaker on…

The House passed Republicans’ “big, beautiful bill” on Thursday in a razor-thin 215-214 vote, sending the legislation — which includes the most drastic overhaul to Medicaid since the program was founded —…

Sanofi has agreed to spend $470 million to take control of a young biotechnology company and its experimental drug for Alzheimer’s disease. The newly announced acquisition has Sanofi paying $8…

For decades now, doctors tasked with diagnosing breast cancer have peered into microscopes and pored over slides, hunting for signs the tumor cells they’re studying harbor a protein known as…

A combination of Roche’s cancer immunotherapy Tecentriq and a drug called Zepzelca helped extend survival in people with a hard-to-treat form of lung cancer, according to clinical trial data made…

Advisers to the Food and Drug Administration have recommended COVID-19 vaccine makers continue to target their shots to the so-called JN.1 coronavirus strain for the upcoming fall and winter seasons,…

Expert advisers to the Food and Drug Administration on Tuesday backed Johnson & Johnson’s Darzalex for people with an asymptomatic form of multiple myeloma that often progresses into more severe…

ReproNovo, a biotechnology company specializing in reproductive medicine, has raised $65 million to advance two drugs it thinks could help address fertility issues in men and women. The Switzerland-based firm…

Today, a brief rundown of news involving Tourmaline Bio, Schrödinger and Beckley Psytech, as well as updates from CRISPR Therapeutics and Regenxbio that you may have missed. Shares in Tourmaline…

The Food and Drug Administration is changing how it reviews new COVID-19 vaccines, setting out stricter standards in place of the framework it used to quickly clear updated boosters for…

Novavax has at last gained full Food and Drug Administration approval for its COVID-19 vaccine, but the OK comes with limitations not specified for other COVID shots available in the…

Prime Medicine will lay off one-quarter of its workforce and deprioritize its clinical-stage program for a rare genetic disease as part of a restructuring announced Monday. Moving forward, Prime will…

Retail and specialty-lite brand teams are facing a paradox – they're drowning in data yet struggling to gain actionable insight. While manufacturers collect vast amounts of information, most are still…

Dive Brief: Sanofi plans to invest at least $20 billion in the U.S. over the next five years as the pharmaceutical industry braces for new tariffs from President Trump. The…

Novo Nordisk CEO Lars Fruergaard Jørgensen, who led the Danish drugmaker to new heights through its development of powerful medicines for diabetes and obesity, will step down from his position,…

Today, a brief rundown of news involving Amgen and Regeneron, as well as updates from Travere Therapeutics, Allogene and Kyverna Therapeutics that you may have missed. A federal jury has…

BioMarin Pharmaceutical has agreed to spend $270 million to take control of a Boston-based drug company with complementary expertise in rare disease research. The all-cash deal, announced Friday, should close…

Connecticut-based Biohaven has been developing what it hopes will be the first medicine for a group of rare, nerve-destroying diseases. The company ran a couple late-stage clinical trials, submitted an…

A group of scientists successfully made a bespoke gene editing medicine for a critically ill baby in just a few months, suggesting CRISPR technology could be used to quickly develop…

Dive Brief: British drugmaker GSK has agreed to pay privately held Boston Pharmaceuticals $1.2 billion upfront and as much as $800 million more to acquire rights to a liver disease…

Dive Brief: Novo Nordisk on Wednesday said it will collaborate with biotechnology startup Septerna to hunt new obesity drug prospects, agreeing to pay the California drugmaker more than $200 million…

President Donald Trump’s declaration Monday that the Department of Health and Human Services will pursue a plan to “equalize” drug prices with other countries both seeks to fulfill a campaign…

The women’s health field has a long way to go addressing persistent deficits in research and treatment. Common conditions that affect women like endometriosis and polycystic ovarian syndrome remain misunderstood,…

The Trump administration is resurrecting a controversial policy that aims to tamp down some pharmaceutical costs in the U.S. by linking them to prices paid abroad, delivering another jolt to…

Safety concerns have spurred the Food and Drug Administration and Centers for Disease Control and Prevention to recommend suspending use of Valneva’s chikungunya vaccine in people at least 60 years…

The number of registered US clinical trials has almost tripled in the last decade, from over 180,000 in 2015 to nearly 520,000 today. Improvements in our understanding of the human…

Emerging biopharma companies are now taking the lead on drug development, with smaller and more agile firms able to meet aggressive timelines and navigate unique logistical and regulatory challenges. From…

Dive Brief: While revenue and profit rose year-over-year during the first quarter at Novo Nordisk, the Danish drugmaker on Wednesday scaled back its financial forecasts for 2025 due to the…

To hear Vinay Prasad tell it, U.S. healthcare is too ready to intervene unnecessarily, use prescription drugs without sufficient evidence of their benefit and put patients at risk of side…

Dive Brief: Gilead on Wednesday became the latest U.S. drugmaker to pledge new investments in U.S. manufacturing, as President Trump threatens the worldwide industry with tariffs. The California biotech said…

Today, a brief rundown of news involving Eli Lilly and Valneva, as well as updates from CRISPR Therapeutics, Vivo Capital and Charles River Laboratories that you may have missed. Eli…

Pittsburgh-based pharmaceutical firm Viatris on Thursday said a pain drug it’s been developing succeeded in two large clinical trials, setting the stage for an approval filing later this year. The…

Four biotechnology companies are laying off staff in the latest examples of cutbacks in a sector struggling to hold its footing amid financial market turmoil. On Thursday, Vor Bio, Korro…

Scientists long believed the human genome consisted mostly of useless DNA. These sequences, after all, aren’t translated into proteins, making them appear as bits of genetic material with no biological…

A panel of Food and Drug Adminsitration advisers will meet May 22 to discuss updating the formula of COVID-19 vaccines ahead of the fall and winter season, according to a draft…

Vinay Prasad, a prolific academic and longtime critic of U.S. drug policies, was named Wednesday as the new leader of a main Food and Drug Administration office. FDA Commissioner Martin…

Shares in more than a dozen gene and cell therapy developers tumbled by double digits Wednesday after a well-known critic of the speedy approval paths their treatments often rely on…

AI drug discovery specialist Recursion Pharmaceuticals is shelving three of its most advanced drug prospects in an effort to cut costs following a merger last year.  Alongside its latest quarterly…

Dive Brief: Shares in PTC Therapeutics fell by double-digits Monday morning as investors parsed new clinical trial results for an important Huntington’s disease drug the biotechnology company has been developing.…

Dive Brief: Madrigal Pharmaceuticals said its pioneering medicine for a common liver disease brought in $137.3 million in the first quarter, surpassing analyst estimates by more than $20 million.  More…

AstraZeneca on Tuesday confirmed it has closed down its neuroscience research group to direct resources toward more “high value” projects. On an earnings call with investors, Sharon Barr, AstraZeneca’s head…

Today, a brief rundown of news involving Arvinas and Biogen, as well as updates from Merck & Co., Entrada Therapeutics and Valneva that you may have missed. Arvinas will lay…

Dive Brief: CVS Health’s pharmacy benefit manager Caremark reached an agreement with Danish drugmaker Novo Nordisk to give its weight loss drug Wegovy preferred access on Caremark’s standard formulary, which…

Today, a brief rundown of news involving Cytokinetics and AstraZeneca, as well as updates from Repare Therapeutics, Amicus Therapeutics and Pliant Therapeutics that you may have missed. The Food and…

Dive Brief: Amgen on Thursday said its just-launched biosimilar of Johnson & Johnson’s autoimmune drug Stelara recorded $150 million in sales in the first quarter, spotlighting rising revenue from the…

The threat of tariffs on pharmaceuticals imported to the U.S. hasn’t yet pushed drugmakers off course, with many of the largest companies indicating they expect to be able to absorb…

The Food and Drug Administration has asked Moderna for additional data before it will consider approving a combination shot the company developed for flu and COVID-19, the latest sign vaccines…

Biotechnology startups usually turn to a few tried-and-true options to raise the money they need to develop a new drug. Company founders might get initial financial help from friends, family…

Novartis will pay $800 million upfront to acquire Regulus Therapeutics, a San Diego biotechnology company that launched nearly two decades ago with plans to make drugs capable of targeting small…

Pfizer will maintain its 2025 financial forecasts for now, but warned Tuesday it can’t predict the impact of any tariffs or trade policy changes the Trump administration might impose on…

A shareholder of immune drug developer Acelyin believes the company is better off shutting down and returning cash to shareholders rather than pursuing a merger with fellow biotech Alumis. Trium…

Dive Brief: Merck KGaA has agreed to buy biotechnology company SpringWorks Therapeutics, announcing Monday a $3.9 billion deal after months of negotiations over an acquisition. The German pharmaceutical firm will…

Novavax claims it can surmount the latest regulatory hurdle hindering its quest to win full U.S. clearance of its COVID-19 vaccine, saying Monday it believes its application is still approvable…

Rare diseases pose a significant challenge for healthcare systems, patients and pharmaceutical companies alike. The journey from symptom onset to diagnosis and treatment can take years—sometimes even decades. The scattered…

Dive Brief: Sanofi’s first-quarter sales and profit exceeded analyst expectations, but the company held tight on its full-year guidance amid looming threats of new tariffs from the Trump administration and…

Caribou Biosciences is laying off about a third of its staff and stopping work on an experimental lupus treatment in a gamble on the potential of a pair of cell…

Today, a brief rundown of news involving Merck and Vanda Pharmaceuticals, as well as updates from Sanofi and Novo Holdings that you may have missed. Halozyme Therapeutics has sued Merck…

Dive Brief: Gilead Sciences on Thursday reported $6.7 billion in revenue in the first quarter, missing consensus Wall Street estimates as its cancer drug sales fell short of analyst expectations.…

Biohaven lost close to $400 million in market value Friday on news that the Connecticut-based drug developer had withdrawn an application to get one of its most advanced experimental therapies…

Dive Brief: Merck & Co. “absorbed” $200 million in addition expenses related to U.S. and overseas tariffs in the first quarter of 2025, increasing its cost of selling products and…

A new, closely watched schizophrenia medication from Bristol Myers Squibb sold well in its first full quarter on the market, according to both the company and analysts. In its latest…

A brain drug at the center of a recent $14 billion acquisition has failed a large clinical trial, leading some Wall Street analysts to substantially lower their sales forecasts. Bristol…

Dive Brief: Veraxa Biotech, a cancer therapy developer backed by Swiss incubator Xlife Sciences, will go public through a combination with a blank-check entity in a deal that will value the…

The Trump administration is radically revising the scale and scope of the federal health workforce. Approximately 1 in 4 employees at the Department of Health and Human Services have been…

Dive Brief: Roche is the latest drugmaking planning to expand drug production in the U.S., announcing Tuesday a pledge to spend $50 billion over five years on new and existing…

A two-drug regimen involving AstraZeneca and Daiichi Sankyo’s Enhertu topped standard therapy in a large study in HER2-positive breast cancer, the companies said Monday. In a Phase 3 trial, a…

Dive Brief: Novo Nordisk asked the Food and Drug Administration to approve a pill version of its popular weight loss drug in obesity earlier this year, a spokesperson confirmed to…

The Food and Drug Administration’s attempt to increase regulatory scrutiny over laboratory developed tests appears to be dead, much to the relief of clinical labs. The FDA is unlikely to…

A draft budget document shows the Trump administration’s plan to slash funding to the Department of Health and Human Services includes substantial cuts to the Food and Drug Administration. The…

Today, a brief rundown of news involving GSK and Bristol Myers Squibb, as well as updates from Elevation Oncology, Bayer and Airna that you may have missed. GSK’s Blenrep has…

The Food and Drug Administration will aim to limit the participation of industry experts in the advisory committees that the agency consults for some regulatory decisions, Martin Makary, the FDA’s…

The Food and Drug Administration on Friday approved a new use for Sanofi and Regeneron’s top-selling immune disease drug Dupixent, clearing the medicine to treat a chronic skin condition that…

A British investment fund has launched with plans to extract tens of billions of dollars it believes to be “trapped” on the balance sheets of struggling, publicly traded biotechnology companies.  …

Dive Brief: French drugmaker Sanofi agreed to pay $125 million to startup Earendil Labs for two drug candidates designed to treat autoimmune and inflammatory bowel diseases. Under the terms of…

Dive Brief: Eli Lilly’s weight loss pill orforglipron succeeded in a Phase 3 clinical trial in diabetes, helping study participants control their blood sugar while hinting at weight loss that…

Bluebird bio is still waiting on a binding takeover bid from Ayrmid Ltd., three weeks after the company said it would pay $15 million more than SK Capital and Carlyle…

The most effective drug for Parkinson’s disease hasn’t changed in 50 years. But fresh research published in one of the country’s top scientific journals is helping build the case for…

The mass layoffs that swept the U.S. health department this month were chaotic and stressful for employees. They may also have been illegal, according to lawyers and federal employment experts.…

Johnson & Johnson is confident it can manage the impact of tariffs on its pharmaceuticals and medical device businesses this year, announcing Tuesday that it will maintain its financial forecast…

The Trump administration is investigating the effects of pharmaceutical imports on national security, disclosing Monday a probe that is likely to lay the foundation for sector-wide tariffs in the near…

Dive Brief: Pfizer is scrapping another obesity pill, announcing Monday it will stop testing an experimental therapy called danuglipron after uncovering a case of possible liver damage in one study…

AdvaMed and nine other healthcare organizations continue to pressure the White House to exempt medical devices and critical supplies from the Trump administration’s tariff policies.  AdvaMed, one of the largest…

Dive Brief: President Trump on Tuesday said he’s planning soon to announce “a major tariff on pharmaceuticals,” which were exempted from the new levies he imposed this month. Trump didn’t…

Dive Brief: Tempest Therapeutics is seeking a buyer or partner, saying Wednesday it has hired financial advisers to “advance its promising clinical stage programs and maximize stockholder value,” as the…

Dive Brief: The Food and Drug Administration aims to phase out animal toxicology testing for experimental drugs, announcing Thursday a plan to reduce, revise or replace such requirements in favor…

Today, a brief rundown of news involving Amgen and the Parker Institute, as well as updates from J&J, Alzheon and Amylyx Pharmaceuticals that you may have missed. Amgen’s bispecific cancer…

Dive Brief: Novartis will substantially expand its U.S. footprint, announcing Thursday plans to spend $23 billion over five years to build six new factories, expand three existing ones and add…

Dive Brief: Biotech executives and venture capital investors are banding together to press Congress to act on Food and Drug Administration layoffs they say are already impacting drug development. In…

The U.S. is pausing most country-specific tariffs for 90 days while raising duties on imports from China to 125%, President Donald Trump announced Wednesday. Most countries besides China will still…

Today, a brief rundown of news involving Ferring Pharmaceuticals and Solu Therapeutics, as well as updates from the American Society of Hematology, Bristol Myers Squibb, and PureTech Health that you…

Dive Brief: The biotechnology company Rallybio is discontinuing its lead candidate for a rare blood disorder in pregnant women after disappointing data from a mid-stage study, sending shares down sharply…

The U.S. risks losing a once-decisive edge over China in biotechnology unless the federal government prioritizes the sector’s advancement with new funding and policies, a bipartisan commission warned in a…

Oncology drugmaker Tango Therapeutics has cut about 20% of its staff, following a year in which it twice trimmed its pipeline of experimental cancer drugs. The company “made the difficult…

GSK is betting potentially billions of dollars that a smaller drug company’s technology can help create new treatments for brain-corroding diseases. Through a licensing deal announced Sunday, GSK has gained…

Dive Brief: Artis BioSolutions emerged from stealth Wednesday, announcing that it has acquired Landmark Bio, an alliance of academic institutions, hospitals and biotech companies founded in 2021 to help turn…

Biotechnology company funding rounds remain larger than they were in 2022 and 2023, in a sign venture firms continue to favor bigger bets rather than parceling their money into smaller,…

Mehmet Oz, a physician and TV personality, was confirmed Thursday by the U.S. Senate to lead the Centers for Medicare and Medicaid Services, which provides health insurance to more than…

The world’s largest pharmaceutical companies mostly steered clear of billion-dollar acquisitions in the early months of this year, perhaps indicating how a tumultuous U.S. political environment has led would-be buyers…

Today, a brief rundown of news involving Sarepta Therapeutics, Novartis and Allakos, as well as updates from CSL Behring and Roche that you may have missed. A group of independent…

Healthcare industry groups and analysts are reeling after President Donald Trump unveiled a sweeping tariff policy Wednesday that could impact global supply chains for everything from needles and catheters to…

The Food and Drug Administration review deadline for Novavax’s COVID-19 vaccine has come and gone without a decision amid a major organizational shakeup that has already resulted in the resignation…

Dive Brief: Roche has stopped enrolling and treating patients in three studies of the gene therapy Elevidys following the death of a 16-year-old patient with Duchenne muscular dystrophy. The European…

The U.S. will implement a universal baseline tariff of 10%, effective April 5, along with increased tariff rates on various countries, President Donald Trump announced at the White House Wednesday.…

Today, a brief rundown of news involving Eisai, Biogen and Sanofi, as well as updates from Opthea, Novartis, and PTC Therapeutics. The saga to get Eisai and Biogen’s newer drug…

A Texas federal court on Monday struck down the Food and Drug Administration’s new rule regulating laboratory developed tests as medical devices, handing a victory to the clinical lab industry.…

Employees across the Department of Health and Human Services began receiving layoff notices Tuesday, following days of anxious waiting to learn who would be included in the Trump administration’s drastic…

Over the past decade, several dozen cell and gene therapies have reached market in the U.S., bringing with them the promise of long-lasting benefits for serious diseases.  Peter Marks’ fingerprints…

Isomorphic Labs, a British company developing new ways to design and develop medicines, said Monday it raised $600 million to advance its artificial intelligence technology. Isomorphic claims its AI platforms…

Eli Lilly plans to appeal a verdict from key drug regulators who say the company’s new treatment for Alzheimer’s disease should not be cleared for the European market. On Friday,…

Dive Brief: Novartis’ radiopharmaceutical drug Pluvicto can now be used much more widely to treat men with a type of metastatic prostate cancer after U.S. regulators on Friday cleared the…

Bluebird bio on Friday received a new buyout offer that surpasses a take-private bid the pioneering gene therapy developer received last month. In a short statement, Bluebird confirmed Ayrmid Ltd.,…

Peter Marks, the Food and Drug Administration’s top vaccine official, abruptly resigned from the agency on Friday, citing disagreement with Health and Human Services Secretary Robert F. Kennedy Jr. Marks,…

The Food and Drug Administration approved on Friday a new type of medicine for people with the rare bleeding disorder hemophilia. Current hemophilia treatments generally try to replace or spur…

Just before 9 a.m. Thursday in Washington, D.C, the Department of Health and Human Services sent out a press release with the subject line: “HHS Announces Transformation to Make America…

The leading eye-care company Alcon on Wednesday said it has acquired a majority stake in Aurion Biotech, capping months of legal wrangling over the future of the cell therapy developer.…

Nkarta is laying off a third of its workforce, and more than half its executive team, in a bid to survive long enough to see if an experimental cell therapy…

The Food and Drug Administration on Wednesday approved the first treatment for the insatiable hunger associated with the rare disease Prader-Willi syndrome, a long-awaited decision that follows an unorthodox pitch…

The U.S. Senate on Tuesday confirmed Johns Hopkins University surgeon Martin Makary to be commissioner of the Food and Drug Administration, giving him authority over an agency that regulates a…

Character Biosciences, a biotechnology startup developing treatments for vision loss, said Tuesday it raised $93 million in a Series B round. The financing will help Character bring its two most…

Dive Brief: Merck & Co. has entered a competitive race for a new type of heart drug, announcing Tuesday it will pay China-based Jiangsu Hengrui Pharmaceuticals $200 million upfront to…

Verve Therapeutics is expanding a gene editing trial for a cholesterol and heart disease treatment into the U.S., the company said Monday after receiving clearance from the Food and Drug…

Dive Brief: Novo Nordisk is expanding its pipeline of obesity medicines, announcing Monday it will pay China-based United Laboratories International Holdings $200 million upfront to license an experimental “triple agonist”…

On Wednesday, Novartis gave a more detailed look at long-awaited clinical data that the company believes will help secure a broad approval for a successor drug to its blockbuster gene…

Dive Brief: Johnson & Johnson is planning a major U.S. expansion, announcing Friday it will spend $55 billion over the next four years on manufacturing, research and development and technology…

Alynlam Pharmaceuticals will sell its drug for a life-threatening heart disease at almost double the cost of other treatments available for the condition, company executives said Thursday. The price of…

Dive Brief: Optum Rx is shifting to a new pharmacy reimbursement model that should result in pharmacies being paid more for brand-name drugs and less for generics. It’s the latest…

Today, a brief rundown of news involving AstraZeneca and Novartis, as well as updates from Editas, Adaptimmune and Pfizer that you may have missed. AstraZeneca will spend $2.5 billion over…

A postponed meeting of vaccine advisers to the Centers for Disease Control and Prevention is now scheduled to take place in April, a spokesperson for the Department of Health and…

The Food and Drug Administration on Thursday approved an Alnylam Pharmaceuticals medicine for a serious heart condition, a decision that should help the biotechnology firm secure its position as one…

Dive Brief: Sanofi agreed to pay $600 million for a therapy in early human testing that may have the ability to “reset” a patient’s immune system and ward off debilitating…

Dive Brief: Optum Rx is moving to eliminate prior authorization requirements for dozens of drugs, the UnitedHealth-owned pharmacy benefit manager said Wednesday, easing a key pain point for physicians and…

Dive Brief: Immunovant gave investors a mixed set of news Wednesday, touting late-stage results for an experimental autoimmune disease drug while saying the company doesn’t currently plan to seek regulatory…

Dive Brief: Prime Medicine will test its gene editing technology as treatment for a rare liver and lung disorder, revealing on Tuesday plans for a research program in alpha-1 antitrypsin…

A young man with Duchenne muscular dystrophy has died following treatment with Sarepta Therapeutics’ gene therapy Elevidys, the company said Tuesday. In a short statement, Sarepta said the patient suffered…

Japan-based Taiho Pharmaceuticals on Monday said it will acquire Switzerland’s Araris Biotech and its antibody-drug conjugate technology for $400 million upfront. The two companies have worked together since 2023, when…

Dive Brief: An experimental cellular medicine developed by Orca Bio outperformed a standard stem cell transplant in treating people with several types of blood cancer by helping avert a potentially…

Merck & Co. on Tuesday opened a new vaccine manufacturing plant in Durham, North Carolina, that will boost the company’s domestic production at a time when President Donald Trump has…

The Inflation Reduction Act seems to be sticking around under the new Trump administration, but potential reforms could be coming. One target is a provision of the law that subjects…

Dive Brief: Ionis Pharmaceuticals is licensing out another experimental medicine, entering an agreement with Ono Pharmaceutical that offers $280 million upfront and as much as $660 million more for reaching…

Today, a brief rundown of news involving Martin Makary, as well as updates from Pliant Therapeutics, Acelyrin and Sutro Biopharma that you may have missed. The Senate Health, Education, Labor…

The Food and Drug Administration on Thursday recommended to influenza vaccine manufacturers which virus strains to include in next season’s shots. Typically, the agency sets its advice after consulting a…

Today, a brief rundown of news involving Harbour BioMed and Gilead Sciences, as well as updates from Geron, Biogen and Genmab that you may have missed. Harbour BioMed on Wednesday…

Gene therapy specialist MeiraGTx is spinning some of its experimental medicines for the central nervous system into a startup that hopes to develop them further using artificial intelligence. Aptly named…

Dive Brief: Mallinckrodt and Endo Pharmaceuticals, which have struggled through bankruptcies related to opioid litigation, said Thursday that they will merge in a cash and stock transaction that will leave…

Dive Brief: Roche has raised its bet on obesity, agreeing to pay Zealand Pharma $1.65 billion to license an experimental shot the Danish company put into a Phase 2b trial…

Artificial intelligence’s promise to accelerate life sciences research has already drawn billions of dollars of investment in recent years, fueling the rise of companies like Recursion Pharmaceuticals. The latest beneficiary…

Dive Brief: Viking Therapeutics is secure production capacity for its experimental obesity drug, announcing Tuesday it will prepay contract manufacturer CordenPharma $150 million to produce up to 200 million injectable and…

2seventy bio, the cell therapy spinout of Bluebird bio, is selling itself to Bristol Myers Squibb after losing most of its market value in its short run as an independent…

Preliminary results from a small clinical trial suggest that a cutting-edge genetic medicine developed by Beam Therapeutics can repair the damaged DNA that gives rise to a rare liver and…

An experimental drug from Mineralys Therapeutics succeeded in a pair of trials in people with stubbornly high blood pressure, the biotechnology company said Monday. Mineralys has been developing the drug,…

Marty Makary, the Johns Hopkins surgeon who President Donald Trump chose to lead the Food and Drug Administration, fended off pressure from Republican and Democratic senators Thursday over a canceled agency…

Dive Brief: Walgreens has entered into a definitive agreement to be acquired by private equity firm Sycamore Partners and leave the public markets, the retail and pharmacy chain said Thursday. …

Jeb Keiper, the longtime head of Nimbus Therapeutics, is stepping down in a planned transition that will promote the biotechnology startup’s top business executive to chief executive officer. Nimbus on…

This week has brought enough announcements and updates to fill a third news roundup. Today, we’ve got a rundown of news from Roche and AskBio, as well as updates from…

Johnson & Johnson is terminating some research for an experimental drug that the company previously predicted could be a multibillion-dollar product. In a statement released Thursday afternoon, J&J said it…

Marty Makary, President Donald Trump’s nominee to run the Food and Drug Administration, said he would undertake an “assessment” of agency staffing if confirmed but didn’t offer any views on…

Optum Rx, a pharmacy benefit manager owned by one of the country’s largest insurance companies, UnitedHealth Group, has added a new, much-anticipated pain drug to some of its commercial formularies. Sold…

A New Jersey-based drug company believes it has enough evidence to seek approval for an experimental, first-of-its-kind pain medication. On Thursday, Tris Pharma released data from a clinical trial of…

Jazz Pharmaceuticals is expanding its foothold in cancer drug research, announcing Wednesday it will pay $935 million to buy Chimerix and an experimental medicine under Food and Drug Administration review…

Dive Brief: Changes to healthcare policy under President Donald Trump could negatively impact the credit ratings of a broad array of healthcare companies, including providers, payers, pharmaceutical companies and medical…

European venture capital firm Sofinnova Partners has raised 1.2 billion euros, or nearly $1.3 billion, in fresh funds to invest in life sciences and healthcare companies, the group announced Tuesday.…

Merck & Co.’s cancer immunotherapy Keytruda is one of the pharmaceutical industry’s biggest successes. The drug's arrival in 2014 introduced a new way of treating cancer and, over time, it…

Dive Brief: Callio Therapeutics on Monday launched with $187 million in Series A funding and a license to a technology that can make antibody-drug conjugates, or ADCs, with multiple tumor-killing…

Eli Lilly will invest tens of billions more dollars in U.S. drug manufacturing in a significant enlargement of plans the Indianapolis company had already described as historic. Lilly, which makes…

Today, a brief rundown of news involving Praxis Medicines and Bristol Myers Squibb, as well as updates from Eli Lilly and Zevra Therapeutics. Shares in Praxis Precision Medicines fell by…

BridgeBio Oncology Therapeutics, a cancer drug startup spun out of biotechnology company BridgeBio Pharma, will go public by merging with a blank-check entity. In a deal announced Friday, BridgeBio Oncology…

Dive Brief: European drug reviewers have “reaffirmed" their positive view of Eisai and Biogen’s Alzheimer’s disease drug Leqembi, clearing the way for an approval decision by the European Commission, the…

Dive Brief: Vertex Pharmaceuticals has pulled out of a planned four-year collaboration with Verve Therapeutics, returning all rights to a preclinical gene editing program for liver disease. Verve announced the…

A meeting of Food and Drug Administration advisers to determine the composition of flu vaccines for the upcoming season has been canceled, a member of the committee confirmed to BioPharma…

Today, a brief rundown of news involving AstraZeneca and Madrigal Pharmaceuticals, as well as updates from Lava Therapeutics, PepGen and Entrada Therapeutics that you might have missed. AstraZeneca said Wednesday…

Eight years ago, Eli Lilly CEO David Ricks stood in front of a red banner emblazoned with the words “Invested in America” to tout an $850 million investment his company…

Eikon Therapeutics, a well-funded drug startup run by Merck & Co.’s former research chief, has raised one of the biggest venture rounds for a biotechnology company so far this year. The…

Dive Brief: Drug compounders are suing the Food and Drug Administration again over obesity and diabetes drugs, claiming in a complaint Monday the agency’s decision to remove Novo Nordisk’s semaglutide…

The biotechnology sector’s foundations rest on basic scientific research. Early experiments done in academic laboratories often yield the discoveries that venture investors later form drug startups around. Investors and industry…

Many people who were fired from the Food and Drug Administration’s medical device center last week had their termination letters rescinded over the weekend, according to the industry group Advamed…

Early-phase clinical trials, including phase 1 and some phase 2a studies, serve as a pivotal step for biotech companies, laying the foundation for a drug candidate’s journey to market. However,…

The sudden firing of Food and Drug Administration employees this past week is already affecting medical device companies. The layoffs could delay the time it takes to bring new products…

Bluebird bio, a pioneering gene therapy developer that in recent years has struggled to stay afloat, has agreed to be acquired and taken private in a deal with investment firms…

Dive Brief: Weak demand for Pfizer’s hemophilia gene therapy Beqvez has led the pharmaceutical company to “cease further development and commercialization” of the one-time treatment, a Pfizer spokesperson confirmed to…

Today, a brief rundown of news involving Novo Nordisk, Acelyrin and Intra-Cellular Therapies, as well as updates from Gilead Sciences and PhRMA that you might have missed. The Food and…

The firing of possibly thousands of people working in U.S. health agencies this past week is likely to ripple across the biomedical ecosystem, affecting basic scientific research and disease tracking…

An upcoming meeting of vaccine advisers to the Centers for Disease Control and Prevention has been postponed, delaying what was set to be the committee’s first gathering after the swearing-in…

Today, a brief rundown of news involving Sanofi and Supernus Pharmaceuticals, as well as updates from Arcus Biosciences, Gilead Sciences and Ultragenyx Pharmaceutical that you might have missed. Sanofi and…

Advamed CEO Scott Whitaker warned the Department of Health and Human Services that job cuts made over the weekend at the Food and Drug Administration could have a “very negative…

Dive Brief: An experimental Duchenne muscular dystrophy gene therapy from Solid Biosciences showed potential in a small clinical trial, leading the biotechnology company to quickly raise funds on the findings.…

Dive Brief: Through a new deal, Biogen has bought access to a potentially first-of-its-kind drug that some doctors and analysts see as a promising treatment for a rare form of…

The Financial Burden of Care Navigating healthcare is challenging for most individuals and families, but for those facing rare or chronic conditions, the obstacles can feel even more overwhelming. They…

The Trump administration has directed federal agencies to “undertake plans for large-scale reductions in force” as part of a sweeping plan to shrink the size of the U.S. government. The…

Dive Brief: Biogen is set to receive as much as $250 million in funding to develop a late-stage experimental lupus medication called litifilimab after signing a deal with Royalty Pharma.…

Scientists believe GLP-1 drugs like Novo Nordisk’s Ozempic help people with obesity lose weight in part because they can help quell food cravings. Intriguing evidence that these drugs may also…

Dive Brief: Sanofi and Johnson & Johnson are ending a Phase 3 study of an experimental E. coli vaccine after it failed to show a significant benefit over placebo in…

Robert F. Kennedy Jr., a prominent vaccine critic who President Donald Trump has directed to “go wild” on healthcare, was confirmed Thursday by the U.S. Senate as the country’s top…

Drug development is a notoriously expensive business. Discovering, testing and advancing a medicine can cost hundreds of millions of dollars, putting immense pressure on young biotechnology companies to be on…

A startup focused on brain drugs officially launched Thursday, backed by $94 million from a group of investors that includes one of the world’s largest banks and the parent company…

Today, a brief rundown of news involving Neumora Therapeutics and Pliant Therapeutics, as well as updates from Biogen, AbbVie and SpringWorks Therapeutics that you might have missed. Neumora Therapeutics CEO…

Dive Brief: Aardvark Therapeutics on Wednesday night raised $94.2 million in an initial public offering that will support development of hunger-suppressing drugs for the rare disease Prader-Willi syndrome and obesity-related…

A federal judge on Tuesday ordered the Food and Drug Administration and other federal health agencies to restore websites that were removed in response to executive orders from President Donald…

Novartis is wagering more than $3 billion that a startup it helped launch six years ago has developed a better blood thinner than what’s now available. The Swiss drugmaker on…

Today, a brief rundown of news involving Merck KGaA and BridgeBio Pharma, as well as updates from Biohaven, Third Harmonic Bio and AdvanCell that you might have missed. Merck KGaA…