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1,310 stories matching this filter · ← front page

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  • FDA releases draft guidance to trim animal testing in cancer drug development
    The FDA's Oncology Center of Excellence announced a draft guidance aimed at reducing unnecessary animal studies in the nonclinical safety assessment of certain oncology drugs. The guidance suggest…
    fda press · 5mo agoRegulatoryPositive↗ source
  • GSK and Ionis report functional cure in 20% of hepatitis B patients with bepirovirsen in early trials
    GSK and Ionis disclosed results from two clinical studies of their RNA‑based injection, bepirovirsen, aimed at achieving a functional cure for chronic hepatitis B. In both trials about one‑fifth o…
    BioPharma Dive · 5mo agoPositive readoutPositive↗ source
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  • CVS adds Lilly’s Foundayo and Zepbound to formularies, leveling GLP-1 market with Novo
    CVS Caremark announced it will place Eli Lilly’s new oral GLP-1 drug Foundayo on its formulary starting June 1 and will restore the injectable Zepbound as a preferred option from Oct 1. The change…
    BioPharma Dive · 5mo agoDealPositive↗ source
  • FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
    Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarr…
    fda press · 5mo agoApprovalPositive↗ source
  • FDA issues warning letters to eight retailers for selling unauthorized tobacco products that mimic candy and other everyday items
    The U.S. Food and Drug Administration announced on May 20, 2026 that it has sent warning letters to eight retailers for offering unauthorized nicotine pouches and dissolvable tobacco products that…
    fda press · 5mo agoRegulatoryNegative↗ source
  • Mentari Therapeutics to go public via reverse merger with InMed, raising $290 million for migraine antibody programs
    Mentari Therapeutics, a spinout of Paragon, announced a reverse merger with InMed Pharmaceuticals that will take the company public under the Mentari name. The deal has received board approval fro…
    BioPharma Dive · 5mo agoDealPositive↗ source
  • BioMarin's BMN-401 fails key endpoint in ENPP1 deficiency Phase 3 trial
    An experimental therapy, BMN 401, was tested in a Phase 3 study for ENPP1 deficiency, a rare disease. The drug missed one of its two co-primary endpoints, a result that regulators consider critical…
    BioPharma Dive · 5mo agoNegative readoutNegative↗ source
  • Relay Therapeutics' zovegalisib shows 60% response in mid‑stage trial for rare vascular anomalies
    Relay Therapeutics reported early data from a phase 2 trial of its experimental drug zovegalisib in patients with vascular anomalies, a group of rare disorders characterized by abnormal blood vesse…
    BioPharma Dive · 5mo agoPositive readoutPositive↗ source
  • FDA approves AstraZeneca’s novel hypertension pill Baxfendy
    The U.S. Food and Drug Administration has cleared AstraZeneca’s new hypertension medication, Baxfendy, marking the first approval of a drug that works by inhibiting a blood‑pressure‑raising enzyme.…
    BioPharma Dive · 5mo agoApprovalPositive↗ source
  • Merck's China-sourced ADC shows survival benefit in Phase 3 endometrial cancer trial
    Merck & Co., in partnership with Chinese biotech Kelun-Biotech, reported that its experimental antibody-drug conjugate sacituzumab tirumotecan (Sac-TMT) met its primary endpoint in a global Phase 3…
    BioPharma Dive · 5mo agoPositive readoutPositive↗ source
  • FDA leadership overhaul follows firing of acting CDER director; 20 deaths linked to Amgen’s Tavneos in Japan
    The FDA announced another leadership change, removing acting directors of its two main drug review centers. Tracy Beth Høeg, acting head of the Center for Drug Evaluation and Research (CDER), poste…
    BioPharma Dive · 5mo agoRegulatoryNegative↗ source
  • Pharma firms turn to outsourcing to boost value of aging drug portfolios
    For many years pharma companies treated legacy brands as low-maintenance cash generators, focusing only on steady but declining revenue once patents expired. With the largest patent cliff in histo…
    BioPharma Dive · 5mo agoPositive↗ source
  • Regeneron immunotherapy combo comes up short in melanoma trial
    A two-drug regimen of Regeneron’s fianlimab and Libtayo didn’t significantly outperform Keytruda in a late-stage study, a finding that surprised Wall Street analysts and wiped out billions in marke…
    BioPharma Dive · 5mo agoRegulatoryNeutral↗ source
  • Sun Pharma’s $12 billion Organon deal signals global push but India still faces R&D hurdles
    Sun Pharma is close to completing a nearly $12 billion purchase of Organon, which would lift the Indian group into the world’s top‑25 pharmaceutical companies and expand its footprint to about 150…
    BioPharma Dive · 6mo agoDealNeutral↗ source
  • FDA places clinical hold on Aardvark’s Prader-Willi drug amid heart safety concerns
    The Food and Drug Administration has issued a clinical hold on Aardvark Therapeutics' experimental treatment ARD-101 for Prader-Willi Syndrome after safety signals were identified. The hold follow…
    BioPharma Dive · 6mo agoRegulatoryNegative↗ source
  • Biotech execs push for Rick Pazdur as FDA chief while Takeda announces 4,500 layoffs
    Hundreds of biotechnology executives, investors and patient advocates have signed a petition urging President Trump to nominate Rick Pazdur as the next FDA commissioner. Pazdur, a longtime FDA vet…
    BioPharma Dive · 6mo agoLayoffsNeutral↗ source
  • Supreme Court blocks lower court ruling, keeps mail-order access to abortion pill mifepristone
    The Supreme Court issued an indefinite stay that preserves mail-order access to the abortion medication mifepristone. The order maintains the ability for providers to prescribe the drug through pha…
    BioPharma Dive · 6mo agoRegulatoryPositive↗ source
  • Regenxbio reports key gene therapy results, moves toward FDA accelerated clearance for Duchenne
    Regenxbio said its experimental gene therapy RGX-202 met the primary endpoint in a pivotal Duchenne muscular dystrophy trial, positioning the company to file for accelerated FDA clearance. In the…
    BioPharma Dive · 6mo agoRegulatoryPositive↗ source
  • Create Medicines secures $122M Series B to advance in vivo CAR-T therapies
    Create Medicines, a Cambridge biotech, announced a $122 million Series B financing to expand its in vivo CAR-T cell therapy platform targeting cancer and autoimmune diseases. The round was co-led…
    BioPharma Dive · 6mo agoDealPositive↗ source
  • Biogen pushing tau drug forward despite Alzheimer’s study failure
    One of the company’s more closely watched research assets, BIIB080 is now heading to late-stage testing based on “the strength of the biomarker and efficacy data” seen in a Phase 2 trial.
    BioPharma Dive · 6mo agoRegulatoryNeutral↗ source
  • FDA leadership gap deepens uncertainty for biotech as acting officials take charge
    Marty Makary's resignation as FDA commissioner has left the agency without a permanent head. Kyle Diamantas is serving as the temporary leader, while three senior drug-review positions are filled b…
    BioPharma Dive · 6mo agoRegulatoryNegative↗ source
  • Lilly data show lower-dose GLP-1 injections and oral pill help sustain weight loss
    Eli Lilly presented new research on how patients who have lost weight with GLP‑1 medicines can maintain that loss over time. The studies followed people who had achieved significant reductions usin…
    BioPharma Dive · 6mo agoPositive readoutPositive↗ source
  • Assertio rejects Garda bid, accepts Zydus offer valuing company at $23.50 per share
    Assertio Holdings announced it has terminated its pending acquisition by Garda Therapeutics after the board approved a higher offer from another suitor. The new proposal from Zydus Worldwide value…
    BioPharma Dive · 6mo agoDealNeutral↗ source
  • Podcast Highlights Community Oncology’s Growing Role in U.S. Cancer Care
    A new sponsored podcast episode explores how community oncology clinics are becoming a vital part of the U.S. cancer‑care landscape. The program, released in May 2026, discusses why these local cen…
    BioPharma Dive · 6mo agoPositive↗ source
  • FDA chief Marty Makary resigns, ending turbulent tenure
    FDA chief Marty Makary has resigned, ending a tenure described as turbulent with leadership upheaval, mass layoffs, political pressure and public disputes with drugmakers. President Trump announce…
    BioPharma Dive · 6mo agoRegulatoryNegative↗ source