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1,988 stories matching this filter · ← front page

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  • 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 · 3mo agoRegulatoryNeutral↗ source
  • FDA Commissioner Marty Makary resigns as Biogen unveils new Alzheimer’s data
    Marty Makary announced his resignation from the role of FDA commissioner, ending his tenure amid recent political developments. Biogen disclosed fresh data from its Alzheimer’s disease program, ad…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
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  • 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 · 4mo 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 · 4mo 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 · 4mo agoLayoffsNeutral↗ source
  • FDA drug division chief Tracy Beth Høeg expected to depart amid leadership shakeup
    Tracy Beth Høeg, who leads the FDA’s Center for Drug Evaluation and Research, is reported to be leaving the agency. Her exit comes shortly after former Commissioner Marty Makary stepped down, sugg…
    Endpoints · 4mo agoRegulatoryNeutral↗ 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 · 4mo agoRegulatoryPositive↗ source
  • Candel Therapeutics shares 20-month follow-up data for its prostate cancer candidate ahead of FDA filing
    Candel Therapeutics announced that it has completed a long-term follow‑up study of patients treated with its prostate cancer drug. The data extend to about 20 months after treatment and are intende…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • FDA Commissioner Marty Makary Resigns After Turbulent Tenure
    Marty Makary stepped down as commissioner of the U.S. Food and Drug Administration on Tuesday, ending a period marked by controversy and intense scrutiny. His resignation follows a series of publi…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Mid-size pharma firms drive surge in biopharma M&A activity
    The article notes that 2026 is shaping up as one of the busiest years for biopharma mergers and acquisitions on record. Unlike previous years dominated by large multinational companies, a broader…
    Endpoints · 4mo agoDealNeutral↗ source
  • Biopharma M&A stays robust as companies shift focus from megadeals to smaller targets
    The article notes that despite a slowdown in large megadeals, overall merger and acquisition activity in the biopharma sector remains strong. Companies are adopting multi‑pronged strategies to add…
    Endpoints · 4mo agoDealNeutral↗ source
  • Amgen tightens 340B program rules, expanding pharmacy claims data requirements
    Amgen announced it is expanding the data it requires from pharmacies that dispense its products under the federal 340B drug discount program. The new policy will obligate participating pharmacies…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Aardvark to unblind rare disease trial after FDA places full clinical hold; Alumis issues verdict on Acelyrin asset
    Aardvark's rare disease candidate is under a full clinical hold by the FDA, which has paused all dosing and data collection. The company says it intends to unblind the trial data despite the hold,…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Supreme Court Keeps Mail Delivery of Abortion Pill Mifepristone in Place
    The Supreme Court issued a ruling on Thursday that preserves the ability to ship the abortion medication mifepristone through the postal service. The decision leaves in place the existing safety r…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • AC Immune CEO Andrea Pfeifer Retires After 23 Years, Company Begins CEO Search
    AC Immune announced that its chief executive Andrea Pfeifer will step down after a 23‑year tenure. Pfeifer, who has guided the biotech through multiple development programs, said she will retire a…
    Endpoints · 4mo agoNeutral↗ source
  • Nonprofits launch Zillow-style marketplace to match abandoned gene and cell therapies with new developers
    Two nonprofit groups announced the launch of an online marketplace designed to give abandoned cell and gene therapy projects a chance for redevelopment. The platform, unveiled at the American Socie…
    Endpoints · 4mo agoPositive↗ source
  • AstraZeneca reports Phase 3 trial shows Imfinzi-Padcev combo improves survival in bladder cancer
    AstraZeneca announced that its Phase 3 study of the immunotherapy Imfinzi combined with the antibody‑drug conjugate Padcev, developed with Pfizer and Astellas, extended overall survival for patient…
    Endpoints · 4mo agoPositive readoutPositive↗ 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 · 4mo 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 · 4mo agoDealPositive↗ source
  • BeOne Medicines receives accelerated FDA approval for sonrotoclax in mantle cell lymphoma
    BeOne Medicines announced that the U.S. Food and Drug Administration granted accelerated approval to its BCL2 inhibitor sonrotoclax for treatment of mantle cell lymphoma. The approval is based on…
    Endpoints · 4mo agoApprovalPositive↗ source
  • Encoded Therapeutics gene therapy cuts seizures 76% in Dravet syndrome children
    Encoded Therapeutics presented data at the ASGCT26 meeting showing its gene therapy achieved a 76% reduction in seizures among children with Dravet syndrome. The result was observed in three patie…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Degron Therapeutics raises $40M in Series A extension, total $95M, as Cabaletta releases early CAR‑T data
    Degron Therapeutics, a US‑China biotech focused on molecular‑glue degrader technology, announced an additional $40 million in Series A extension funding, bringing its total capital raised to $95 mi…
    Endpoints · 4mo agoDealNeutral↗ source
  • Biogen's anti-tau Alzheimer drug BIIB080 fails primary endpoint in Phase 2, but shows slower decline
    Biogen reported results of its Phase 2 trial of BIIB080, a tau-targeting therapy for Alzheimer’s disease. The study’s primary endpoint was not met, meaning the drug did not achieve the pre-specifi…
    Endpoints · 4mo agoNegative readoutNeutral↗ source
  • Regenxbio reports positive Duchenne gene therapy trial results, targets FDA approval by 2027
    Regenxbio announced that its gene therapy for Duchenne muscular dystrophy achieved the required endpoints in a pivotal clinical trial. The data met the study's predefined criteria, which the compa…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • MacroGenics sells manufacturing operations to Bora for $122.5M; West Pharma reports cybersecurity breach
    MacroGenics announced it is selling its clinical and commercial drug substance manufacturing portfolio to CDMO Bora. The deal includes an upfront payment of $122.5 million. The transaction transfe…
    Endpoints · 4mo agoDealNeutral↗ source