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1,192 stories matching this filter · ← front page

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  • FDA moves to reverse policies of former commissioner Marty Makary
    The Trump administration is actively rolling back decisions made under former FDA commissioner Marty Makary. As the White House weighs a new nominee for the agency, officials have begun revisiting…
    Endpoints · 23d agoRegulatoryNegative↗ source
  • Former FDA oncology chief calls for agency restructuring after recent staff cuts
    Richard Pazdur, who led the FDA’s Oncology Center of Excellence for more than twenty years, said the agency now faces a "golden opportunity" to restructure its operations. He made the comments aft…
    Endpoints · 23d agoRegulatoryNeutral↗ source
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  • Gilead and Merck to unveil detailed Phase 3 results of once‑weekly oral HIV regimen at AIDS 2026; Dimension Capital launches $800M fund
    Gilead Sciences and Merck announced that they will present detailed results from their Phase 3 trials of a once‑weekly oral HIV treatment regimen at the upcoming AIDS 2026 conference. The data wil…
    Endpoints · 24d agoNeutral↗ source
  • Agios halts sickle cell drug program after disappointing phase 2 results
    Agios announced it is stopping development of its next‑generation pyruvate kinase activator, tebapivat, for sickle cell disease after a phase 2 trial failed to meet expectations. The study enrolle…
    Fierce Biotech · 25d agoNegative readoutNegative↗ source
  • FDA issues warning letter to Alembic Pharmaceuticals over missing patient consent in clinical study
    The U.S. Food and Drug Administration sent a warning letter to Indian generic manufacturer Alembic Pharmaceuticals after it was found to have failed to obtain informed consent from participants in…
    Endpoints · 24d agoRegulatoryNegative↗ source
  • Biotech firms rally to defend FDA's mifepristone approval in Louisiana lawsuit
    Biotech companies, executives and investors filed an amicus brief supporting the FDA in the Louisiana case that seeks to limit access to the abortion pill mifepristone. The brief is signed by 61 e…
    Fierce Biotech · 24d agoRegulatoryPositive↗ source
  • FDA to appoint permanent heads of CBER and CDER alongside new commissioner
    The FDA is preparing to announce a series of senior leadership changes concurrent with the appointment of a new commissioner. Among the planned announcements are permanent appointments for the hea…
    Endpoints · 24d agoRegulatoryNeutral↗ source
  • Agios halts development of next‑generation sickle‑cell drug tebapivat after disappointing mid‑stage trial
    Agios Therapeutics announced it will discontinue development of tebapivat, a next‑generation therapy for sickle cell disease, after the drug failed to demonstrate sufficient efficacy in a Phase 2 t…
    Endpoints · 24d agoNegative readoutNegative↗ source
  • Broad Institute partners with Boston Children’s Hospital and Jackson Lab to launch Center for Therapeutic Genetics for rare diseases
    The Broad Institute of MIT and Harvard announced a partnership with Boston Children’s Hospital and the Jackson Laboratory to create a Center for Therapeutic Genetics focused on rare diseases. The…
    Endpoints · 24d agoPositive↗ source
  • Jupiter Neurosciences signs $100M deal for U.S. rights to PharmAla's MDMA therapy ALA-002
    Jupiter Neurosciences announced a licensing agreement with Canadian biotech PharmAla Biotech to obtain U.S. rights to an MDMA‑based drug, ALA‑002, aimed at treating neuropsychiatric conditions. Th…
    Fierce Biotech · 24d agoDealPositive↗ source
  • Novartis halts phase-2 radioligand therapy Lu-NeoB after disappointing data, but reaffirms commitment to RLT
    Novartis announced it is halting development of Lu-NeoB, a gastrin-releasing peptide receptor-targeting radioligand therapy, after phase-2 data failed to demonstrate sufficient efficacy. The candi…
    Fierce Biotech · 25d agoNegative readoutNegative↗ source
  • Lupin spins out two phase-1 cancer candidates into US startup Kaveri, taking majority stake and providing seed funding
    Lupin, an Indian generics manufacturer, has created a U.S.-based spinout called Kaveri Therapeutics by transferring two clinical-phase cancer drug candidates. The assets are a PRMT5 inhibitor (LNP…
    Fierce Biotech · 25d agoDealNeutral↗ source
  • Novo Nordisk files lawsuit against Eli Lilly over allegedly deceptive GLP-1 dose ads
    Novo Nordisk has initiated legal action against Eli Lilly in a U.S. court, alleging that Lilly's recent advertisements misrepresent the dosing of GLP-1 obesity treatments. The company says the ads…
    Endpoints · 24d agoNegative↗ source
  • Ashlins Pharma licenses interferon alpha-2b from Lee's, eyes $50M raise to pursue FDA approval for rare disease
    Ashlins Pharmaceuticals has signed a licensing agreement with Hong Kong‑based Lee’s Pharmaceutical to obtain the ex‑China rights to a Chinese formulation of interferon alpha‑2b. The deal, announced…
    Fierce Biotech · 24d agoDealPositive↗ source
  • Novartis CEO says China partnerships driven by science, not market strategy
    Novartis chief executive Vas Narasimhan told reporters during the second quarter earnings call that the company’s recent agreements in China are motivated by scientific opportunities rather than a…
    Endpoints · 24d agoDealNeutral↗ source
  • ‘We’ve been looking for a novel approach’: Why Novartis CEO ended ADC holdout for $1.5B Myricx deal
    For years, as Big Pharma poured billions into ADCs, Novartis CEO Vas Narasimhan notably stayed on the sidelines. Asked by Fierce during Novartis’ Q2 earnings call, Narasimhan explained why he is en…
    Fierce Biotech · 24d agoDealNeutral↗ source
  • A-Alpha Bio launches AI antibody data consortium with GSK, Boltz and partners
    A-Alpha Bio, a spin‑out founded by David Baker, announced the creation of a new consortium focused on sharing antibody design data. The group aims to address a shortage of high‑quality data that b…
    Endpoints · 24d agoDealPositive↗ source
  • Roche appoints Dan Malarek as President and CEO of Diagnostics North America, creates new CCO role
    Roche announced that Dan Malarek, who has led Foundation Medicine since 2023, will become President and CEO of Roche Diagnostics North America. Malarek, a 19‑year veteran of Roche, will succeed Br…
    Fierce Biotech · 25d agoPositive↗ source
  • FDA advisory panel to consider reclassifying several widely used peptides
    An FDA advisory committee is meeting this week to decide whether it will recommend reclassifying a group of popular peptide products. The discussion comes as the industry watches closely for any sh…
    Endpoints · 24d agoRegulatoryNeutral↗ source
  • Crystalys mines $130M series B to push gout drug through phase 3
    Crystalys Therapeutics has raised $130 million in series B financing to advance the development of its gout drug dotinurad and prepare for a potential commercial launch.
    Fierce Biotech · 24d agoNeutral↗ source
  • PT Organics recalls select Pumpkin Tree banana‑strawberry puree pouches over possible soft plastic contamination
    PT Organics Limited of Lake Oswego, Oregon announced a voluntary recall of certain Pumpkin Tree Peter Rabbit Organics Banana & Strawberry Fruit Puree pouches. The recall is due to an internal pack…
    fda recalls · 24d agoCRLNeutral↗ source
  • Fresh & Ready Foods recalls Spicy Breakfast Burritos over undeclared soy
    Fresh & Ready Foods LLC announced a recall of its Sprig & Sprout and Fresh and Ready Spicy Breakfast Burritos because they may contain undeclared soy. The problem was traced to inadvertent inclusi…
    fda recalls · 25d agoRegulatoryNegative↗ source
  • Tempus acquires Personalis for $1.5 billion to expand cancer genomics and MRD testing
    Tempus announced it will purchase Personalis in a transaction valued at $1.5 billion, giving it full ownership of the cancer‑genomics firm. The deal builds on a 2023 partnership where Tempus inves…
    Fierce Biotech · 25d agoDealPositive↗ source
  • Samsung Biologics to acquire Swiss CDMO PolyPeptide for $1.8 billion, entering peptide API market
    Samsung Biologics announced a plan to purchase Swiss contract development and manufacturing organization PolyPeptide for $1.8 billion in cash. The acquisition will extend Samsung Biologics' manufa…
    Endpoints · 25d agoDealPositive↗ source
  • Scribe Therapeutics targets $96 million IPO to fund PCSK9 gene-silencing program
    Scribe Therapeutics, a Bay Area biotech focused on genetic medicines, filed with the SEC outlining plans for an initial public offering on Nasdaq. The company aims to sell 7.1 million shares at $1…
    Fierce Biotech · 25d agoDealPositive↗ source