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19 stories matching this filter · ← front page

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  • Lilly pens deal with Gateway Labs alumni Amplitude for RNA vaccine platform for infectious disease
    Eli Lilly has turned to one of its Gateway Labs residents to help the Big Pharma develop trans-amplifying RNA (taRNA) vaccines for infectious diseases.
    Fierce Biotech · 7h ago↗ source
  • Regeneron halts Phase 1/2a uveitis trial of anti-CD3 antibody after safety event
    Regeneron announced it is voluntarily ending the Phase 1/2a TITAN study of its anti‑CD3 monoclonal antibody, REGN7041, which was being evaluated for non‑infectious posterior uveitis. The decision…
    Fierce Biotech · 3d agoCRLNegative↗ source
73
fda recalls47
fda medwatch37
fda press28
899
Psychiatry & CNS712
Ophthalmology421
Endocrinology & Metabolism380
Pain373
Infectious Disease353
Former Legend Biotech CEO Ying Huang appointed head of K2 Therapeutics
K2 Therapeutics announced that Ying Huang, who recently left his role as CEO of Legend Biotech, will now lead the young biotech company. The appointment comes just weeks after Legend announced Huan…
Fierce Biotech · 7d agoNeutral↗ source
  • Combination therapy including leronlimab clears HIV in infant macaques, offering new cure hope
    CytoDyn researchers tested leronlimab together with broadly neutralizing antibodies and antiretroviral therapy in a cohort of 55 infant macaques. Only the eight animals that received the full three…
    Fierce Biotech · 8d agoPositive readoutPositive↗ source
  • Roche launches cyclospora PCR tests as lettuce-linked outbreak spreads across 15 US states
    Roche Diagnostics announced the rollout of two new real-time PCR assays that detect the parasite Cyclospora cayetanensis. The launch comes as the CDC and FDA report that the cyclospora outbreak li…
    Fierce Biotech · 13d agoPositive↗ source
  • FDA grants accelerated approval to Tudriqev viral therapy for PD-1-refractory advanced melanoma
    The U.S. Food and Drug Administration has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically engineered oncolytic viral therapy for patients with advanced, tre…
    fda press · 13d agoApprovalPositive↗ source
  • Vedanta Biosciences secures $60 million to complete Phase 3 trial of C. difficile microbiome therapy
    Vedanta Biosciences, a Cambridge, MA biotech focused on microbiome therapeutics, announced it has raised $60 million in new financing. The capital will be used to advance its lead candidate target…
    Endpoints · 14d agoDealPositive↗ source
  • Fecal microbiome transplant boosts peanut tolerance sixfold in early trial
    Researchers at Boston Children’s Hospital conducted a small open‑label phase 1 trial in which 15 adult participants received oral encapsulated fecal microbiome transplantation to test safety and ef…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • Expedition Therapeutics raises $115M Series B to fund phase 2 COPD trial of DPP1 inhibitor
    Expedition Therapeutics, backed by Sanofi, announced a $115 million Series B financing round. The round was led by General Atlantic with participation from RA Capital, Vivo Capital, and existing i…
    Fierce Biotech · 16d agoDealPositive↗ source
  • Moderna delays norovirus vaccine readout, cites insufficient infections
    Moderna announced that its norovirus vaccine trial will not yield efficacy data this season because infection rates were lower than expected. The company said it will open an additional trial coho…
    Endpoints · 20d agoNegative readoutNeutral↗ source
  • Merck launches voluntary licensing for investigational monthly HIV PrEP pill ahead of approval
    Merck has signed voluntary licensing agreements to allow generic manufacturers to produce its investigational monthly HIV PrEP pill, alimatravir, before any regulatory submission. The agreements c…
    Fierce Biotech · 27d agoDealPositive↗ source
  • ‘Substantially better than before’: Why India has golden opportunity to build on innovative R&D wins
    A string of recent wins on the frontiers of novel drug development could mean that a homegrown innovation industry is within reach.
    Fierce Biotech · 1mo agoNeutral↗ source
  • Ipsen to scoop up Memo Therapeutics and its kidney infection drug
    Ipsen is on an M&A roll. The French drugmaker announced its second deal of the week, saying it would buy Memo Therapeutics and its drug candidate called potravitug for a viral ...
    Endpoints · 1mo ago↗ source
  • FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
    The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an in…
    fda press · 2mo ago↗ source
  • FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats
    FDA today issued an Emergency Use Authorization (EUA) for generic Nitenpyram Tablets (nitenpyram) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and k…
    fda press · 2mo ago↗ source
  • Exclusive: Genentech closes infectious disease unit in wave of research layoffs
    Roche's Genentech underwent another round of layoffs this week in its early research and development group, Endpoints News has learned, which included shuttering two research units and the departur…
    Endpoints · 2mo ago↗ 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 · 3mo ago↗ source
  • Fierce Biotech Layoff Tracker 2026: Kolon cuts workforce after ph. 3 fail; Sanofi sheds 229 staffers
    As always, if you know of layoffs occurring at a biotech, please reach out to the Fierce Biotech editorial team.
    Fierce Biotech · 8mo ago↗ source
  • Fierce Biotech Fundraising Tracker '26: Abcuro secures $66M; InduPro assembles $77M
    The Fierce Biotech Fundraising Tracker records venture capital rounds of $50 million or more secured by biotechs.
    Fierce Biotech · 8mo ago↗ source