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587 stories matching this filter · ← front page

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  • Capricor shares jump as FDA signals openness to review updated Duchenne therapy
    Capricor Therapeutics saw its stock rise sharply after CEO Linda Marbán told analysts that the FDA is willing to look at an amended filing for its Duchenne muscular dystrophy cell therapy, deramioc…
    BioPharma Dive · 11h agoRegulatoryPositive↗ source
  • FDA grants accelerated approval to Bristol Myers' Zenbexus, first CELMoD for multiple myeloma
    The FDA issued an accelerated approval on Thursday for Zenbexus, a multiple myeloma therapy that Bristol Myers Squibb inherited from its Celgene acquisition. Zenbexus belongs to a new class of pro…
    BioPharma Dive · 8h agoApprovalPositive↗ source
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Infectious Disease324
  • 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 · 13h agoPositive↗ 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 · 1d 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 · 1d agoDealNeutral↗ source
  • FDA grants emergency use authorization for Simparica TRIO to treat New World screwworm in dogs and puppies
    The U.S. Food and Drug Administration issued an Emergency Use Authorization for Simparica TRIO, a chewable tablet containing sarolaner, moxidectin and pyrantel, to treat New World screwworm infesta…
    fda press · 1d agoRegulatoryPositive↗ 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 · 1d agoRegulatoryNegative↗ 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 · 2d agoPositive readoutPositive↗ 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 · 2d 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 · 2d agoDealPositive↗ 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 · 2d agoRegulatoryNegative↗ source
  • Kettle Cuisine recalls Marketside Tomato Bisque Soup Kit sold at Walmart over possible Listeria contamination
    Kettle Cuisine LLC announced a recall of its 14‑oz Marketside Tomato Bisque Soup Kit after discovering a potential contamination with Listeria monocytogenes. Listeria can cause severe illness, esp…
    fda recalls · 2d agoRegulatoryNegative↗ source
  • Oma's Pride recalls one lot of Woof Complete Canine Chicken Recipe due to possible Salmonella contamination
    Oma's Pride of Avon, Connecticut announced a voluntary recall of a single lot (BB012729) of its 6‑lb Woof Complete Canine Chicken Recipe pet food after testing identified Salmonella contamination.…
    fda recalls · 2d agoRegulatoryNegative↗ source
  • Whole Foods recalls dips, salsas and other prepared foods containing jalapeños over possible Salmonella risk
    Whole Foods Market announced a recall of select produce and prepared-food items that contain jalapeños supplied by Coast Citrus Distributors because of a potential Salmonella contamination. The re…
    fda recalls · 2d agoCRLNegative↗ source
  • Epicrispr raises $90 million to push epigenetic editing drug EPI-321 for rare muscle disorder FSHD
    Epicrispr Biotechnologies announced a $90 million Series C financing to accelerate development of its epigenetic editing therapy EPI-321 for facioscapulohumeral muscular dystrophy (FSHD), a rare ge…
    BioPharma Dive · 3d agoDealPositive↗ source
  • Infinimmune secures $75 million Series A to develop longer-lasting eczema antibody therapies
    Infinimmune, a biotech based in Alameda, California, announced on Tuesday that it has closed a $75 million Series A financing round. The capital will support the development of its first two clinic…
    BioPharma Dive · 3d agoDealPositive↗ source
  • Trump signs executive order to split MMR vaccine and reduce U.S. childhood immunization schedule
    President Donald Trump signed an executive order on Monday that calls for a reduced U.S. childhood vaccine schedule, lowering the number of universally recommended shots from 17 to 11. The order d…
    BioPharma Dive · 3d agoRegulatoryNegative↗ source
  • Former Legend Biotech CEO Ying Huang appointed head of K2 Therapeutics as startup secures $50M seed funding
    Ying Huang, who led Legend Biotech for seven years and helped develop a top‑selling cell therapy for multiple myeloma, has been named chief executive of K2 Therapeutics. The young company, founded…
    BioPharma Dive · 3d agoDealPositive↗ source
  • Vaderis raises $152 million to launch late-stage trials of AKT inhibitor engasertib for rare bleeding disorder
    Vaderis Therapeutics announced a $152 million Series B financing round, giving it sufficient capital to advance its experimental AKT-targeting drug, engasertib. The company has also begun late-sta…
    BioPharma Dive · 3d agoDealPositive↗ source
  • Lidl US Recalls Vitasia Asian Style Wok Spice Mix Due to Potential Salmonella Contamination
    ARLINGTON, VA – AUGUST 11, 2026 – Lidl US is recalling one lot of Vitasia Asian Style Wok Spice Mix 1.58 oz (45g) (UPC 4335619355491) with Lot # 155846 and BBD JUN 2028 because it has the potential…
    fda recalls · 3d agoRegulatoryNeutral↗ source
  • Henkel recalls Schwarzkopf Professional Osis Grip mousse in U.S. over packaging leak risk
    Henkel Corp announced a voluntary recall of its Schwarzkopf Professional Osis Grip mousse (6.76 fl oz/200 ml) sold in the United States. The recall is due to a potential packaging defect that coul…
    fda recalls · 3d agoCRLNegative↗ source
  • Frankie's Organic recalls vegan cheddar puffs over undeclared milk, warning allergic consumers
    Frankie's Organic Foods Inc. announced a recall of 94 cases of its Plant-Based Vegan Cheddar Puffs after discovering the snack may contain undeclared milk, creating a serious risk for people with m…
    fda recalls · 3d agoCRLNegative↗ source
  • Scribe Therapeutics launches first gene‑editing IPO in over two years, targeting high‑cholesterol gene
    Scribe Therapeutics, a gene‑editing biotech based in California, announced its initial public offering, the first for a CRISPR‑focused company in more than two years. The company, founded by resea…
    BioPharma Dive · 4d agoDealPositive↗ source
  • Jazz Pharmaceuticals to acquire Actio Biosciences in deal worth over $1.3 billion
    Jazz Pharmaceuticals announced an agreement to purchase Actio Biosciences, a San Diego biotech focused on genetic epilepsies. The transaction could total just over $1.3 billion, with $820 million…
    BioPharma Dive · 4d agoDealPositive↗ source
  • Sionna’s cystic fibrosis candidate misses primary endpoint in Phase 2 trial, shares plunge
    Sionna Therapeutics announced that its experimental cystic fibrosis drug SION-719 failed to meet the primary endpoint in a Phase 2 trial that added the drug to Vertex Pharmaceuticals' Trikafta. Th…
    BioPharma Dive · 4d agoNegative readoutNegative↗ source