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807 stories matching this filter · ← front page

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  • New state and federal funding fuels biotech hub growth in Pennsylvania, Kansas City and beyond
    Government programs in Pennsylvania, New York, Kansas City and Central Virginia are pouring new funding into regional biotech hubs as pharma manufacturing investment surges. Matt Gardner, sector p…
    BioPharma Dive · 10d agoPositive↗ source
  • Capricor plans FDA amendment after advisory committee rejects cardiomyopathy endpoint, stock jumps
    Capricor Therapeutics received a negative vote from an FDA advisory committee on the efficacy of its cell therapy, deramiocel, for treating cardiomyopathy in Duchenne muscular dystrophy. The nine‑t…
    Fierce Biotech · 10d agoRegulatoryPositive↗ source
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Infectious Disease373
  • MapLight shifts focus to schizophrenia drug after mixed Phase 2 results, raises $150 million
    MapLight Therapeutics reported mixed outcomes from its Phase 2 Zephyr trial of the muscarinic agonist ML-007C-MA. A twice‑daily dose achieved the study’s primary endpoint with notable reductions in…
    Fierce Biotech · 11d agoDealNeutral↗ source
  • BioCryst to rely on external partnerships after ending internal discovery programs
    BioCryst Pharmaceuticals CEO Charlie Gayer told Fierce that the company remains committed to science and research even as it shuts down its internal discovery efforts. Earlier this year the firm’s…
    Fierce Biotech · 10d agoNeutral↗ source
  • Exotique Foods recalls Momchipz Veggie Chips for possible undeclared gluten
    Exotique Foods Inc of Ontario announced a recall of its Momchipz Veggie Chips in the broccoli florets and cauliflower flavor because the product may contain undeclared gluten. The chips, sold in 3…
    fda recalls · 10d agoCRLNegative↗ source
  • The Hampton Grocers recalls 8-oz Lacnola Lactation Granola over possible Salmonella contamination
    The company announced a recall of its 8-oz Lacnola Lactation Granola due to potential Salmonella contamination. The product was sold nationwide through the company's website and other online retai…
    fda recalls · 10d agoRegulatoryNeutral↗ source
  • Exotique Foods recalls Momchipz Veggie Chips over undeclared wheat risk
    Exotique Foods Inc announced a recall of its Momchipz Veggie Chips Broccoli Florets & Cauliflower because the product may contain undeclared wheat, posing a serious allergy risk. The chips, sold t…
    fda recalls · 10d agoCRLNegative↗ source
  • Taiho and Cullinan report positive Phase 3 results for zipalertinib in EGFR exon 20 insertion lung cancer
    Taiho Oncology and Cullinan Therapeutics announced that their experimental drug zipalertinib achieved positive results in a Phase 3 trial for first‑line treatment of lung cancer patients whose tumo…
    BioPharma Dive · 11d agoPositive readoutPositive↗ source
  • PTC Therapeutics agrees to pay up to $211 million for Sangamo’s experimental Fabry disease gene therapy
    PTC Therapeutics announced it will invest up to $211 million to acquire rights to an advanced gene therapy for Fabry disease being developed by Sangamo Therapeutics. The therapy, called ST-920 (is…
    BioPharma Dive · 11d agoDealNeutral↗ source
  • PDS Biotechnology pauses phase 3 head-and-neck trial to prioritize colorectal cancer immunotherapy
    PDS Biotechnology announced it is stopping work on its phase 3 head and neck cancer therapy, Versamune HPV (PDS0101), in order to reallocate resources to a different drug program. The halted trial…
    Fierce Biotech · 11d agoNeutral↗ source
  • PTC Therapeutics acquires Sangamo’s Fabry gene therapy program for $111 million upfront
    PTC Therapeutics announced it has purchased the Fabry disease gene-therapy program (ST-920) from Sangamo Therapeutics. The deal provides $111 million in upfront cash and includes up to $100 millio…
    Fierce Biotech · 11d agoDealPositive↗ source
  • Versa Vascular appoints former Medtronic heart franchise leader Bill Shields as CEO
    Bill Shields, who spent 15 years leading Medtronic’s structural heart franchise, is leaving the medtech giant to become chief executive of Versa Vascular, a startup developing tricuspid valve repai…
    Fierce Biotech · 12d agoDealPositive↗ source
  • Zealand Pharma sells its rights to Takeda's rusfertide for $100 million ahead of FDA decision
    Zealand Pharma has agreed to sell its economic interest in rusfertide, a peptide drug being developed by Takeda and Protagonist Therapeutics, for $100 million. The transaction comes as the FDA rev…
    Fierce Biotech · 12d agoDealNeutral↗ source
  • 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 · 11d agoNeutral↗ source
  • Grand Central Bakery recalls potato sourdough loaves over possible metal fragments
    Grand Central Bakery of Seattle announced a recall of its potato sourdough bread after discovering that some loaves may contain pieces of metal. The recall includes 20‑oz, 12‑oz and other sized lo…
    fda recalls · 11d agoRegulatoryNegative↗ source
  • Cullinan tees up J&J fight—and $100M payday—as Taiho-partnered drug hits phase 3 cancer goal
    Taiho Pharmaceutical and Cullinan Therapeutics have celebrated a second phase 3 victory for their small-molecule EGFR inhibitor, teeing up the partners to challenge Johnson & Johnson in a lung canc…
    Fierce Biotech · 12d agoNeutral↗ source
  • Grand Central Bakery recalls Potato Sourdough loaves over possible metal contamination
    Grand Central Bakery of Seattle announced a recall of its Potato Sourdough bread after discovering that some loaves might contain metal fragments. The recall covers loaves sold on August 10, 2026…
    fda recalls · 11d agoNegative↗ source
  • Definium's LSD pill shows positive results in late-stage anxiety trial
    Definium Therapeutics reported that its pharmaceutical-grade LSD formulation, DT120, achieved positive outcomes in a late-stage study targeting generalized anxiety disorder. The trial used a 56-po…
    BioPharma Dive · 12d agoPositive readoutPositive↗ source
  • AI monitoring tool could generate up to 82-fold ROI in phase-3 oncology trials, study finds
    An analysis by the Tufts Center for the Study of Drug Development found that an artificial-intelligence clinical monitoring agent can produce an estimated 82-fold return on investment in phase-3 on…
    Fierce Biotech · 12d agoPositive↗ source
  • Former Pfizer chemist launches Khartis Therapeutics with $95M to develop oral thyroid eye disease drug
    Robert Hoffman, a veteran Pfizer chemist who previously co‑founded XinThera, announced the launch of Khartis Therapeutics. The new company, formed in 2024 with other former XinThera leaders, aims t…
    Fierce Biotech · 12d agoDealPositive↗ source
  • Silence Therapeutics' Phase 2 trial shows strong results for divesiran in polycythemia vera, shares jump 30%
    Silence Therapeutics reported that its nucleic‑acid drug divesiran achieved a 69% placebo‑adjusted response rate in a Phase 2 study of polycythemia vera patients. Safety was reported as clean, with…
    BioPharma Dive · 12d agoPositive readoutPositive↗ source
  • Boulevard Bio launches with $65 million to develop bispecific antibodies for IgA nephropathy and other autoimmune diseases
    Boulevard Bio, a new biotech co-founded by autoimmune researcher Georg Schett and former Sanofi CSO Frank Nestle, announced its launch on Wednesday with $65 million in funding. The company’s first…
    BioPharma Dive · 12d agoDealPositive↗ source
  • Aardvark Therapeutics abandons phase 3 trials after workforce cuts and FDA hold
    Aardvark Therapeutics announced it is walking away from its recently terminated phase 3 trials, stating there are no plans to resume them as originally designed. The decision follows a reduction i…
    Fierce Biotech · 12d agoRegulatoryNegative↗ source
  • Samsung gets FDA clearance for Galaxy Buds hearing-aid features
    Samsung Electronics received FDA clearance for new software features in its Galaxy Buds earphones that let them function as over-the-counter hearing aids and conduct hearing tests. The hearing tes…
    Fierce Biotech · 12d agoApprovalPositive↗ source
  • Eli Lilly sues to curb black-market sales of experimental obesity drug retatrutide
    Eli Lilly announced it has filed six new lawsuits aimed at stopping black-market sales of its experimental obesity medicine retatrutide. The legal actions target online merchants, clinics, compound…
    BioPharma Dive · 12d agoRegulatoryNegative↗ source