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463 stories matching this filter · ← front page

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  • Argenx reports positive Phase 3 results for Vyvgart Hytrulo in myositis
    Argenx announced that its subcutaneous formulation of Vyvgart, named Vyvgart Hytrulo, met the primary endpoint in a late‑stage Phase 3 trial in patients with myositis. The trial combined participa…
    BioPharma Dive · 6d agoPositive readoutPositive↗ source
  • EyePoint shares tumble as Durayvu misses primary goal in wet AMD trial
    EyePoint, a Boston biotech, saw its market value drop by nearly $1 billion after its lead candidate Durayvu failed to demonstrate non-inferiority to aflibercept in a pivotal phase 3 trial for wet a…
    BioPharma Dive · 6d agoNegative readoutNegative↗ source
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73
fda recalls49
fda medwatch41
fda press28
918
Psychiatry & CNS737
Ophthalmology428
Pain409
Endocrinology & Metabolism390
Infectious Disease369
  • AstraZeneca halts Phase 3 lung cancer trial of bispecific antibody volrustomig after interim data miss survival goal
    AstraZeneca announced termination of the Phase 3 study of its experimental bispecific antibody volrustomig in non‑small cell lung cancer. An interim data review by trial monitors indicated the dru…
    BioPharma Dive · 6d agoNegative readoutNegative↗ source
  • Becton Dickinson recalls intraosseous needle sets over risk of obturator removal difficulty
    Becton Dickinson has issued a recall for specific intraosseous vascular access system needle sets after discovering that the obturator (stylet) can be difficult to remove once the device is placed.…
    fda medwatch · 7d agoCRLNegative↗ source
  • Slate Medicines to merge with Fulcrum Therapeutics after Fulcrum drops sickle-cell drug
    Slate Medicines announced it will combine with Fulcrum Therapeutics in a reverse merger, giving the struggling biotech a new corporate home. Fulcrum had been developing pociredir, a therapy design…
    BioPharma Dive · 6d agoDealNegative↗ source
  • Oma's Pride recalls one lot of 6 lb Woof Complete canine chicken food after 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 revealed Salmonella contamination.…
    fda recalls · 6d agoCRLNeutral↗ source
  • 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 · 9d 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 · 9d agoApprovalPositive↗ source
  • 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
  • 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 · 9d 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 · 9d agoRegulatoryNeutral↗ 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 · 10d 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 · 10d agoDealNeutral↗ source
  • Baxter recalls Duo-Vent IV solution sets over risk of air bubbles in patients
    Baxter has issued a recall of its Duo-Vent solution sets and male Luer lock adapters after the FDA identified a risk that the devices could contain air bubbles in the drip chamber and tubing. The…
    fda medwatch · 11d agoCRLNegative↗ 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 · 10d agoRegulatoryNegative↗ 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 · 10d 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 · 11d 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 · 11d 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
  • Medline issues correction for convenience kits containing recalled ICU Medical pain management components
    Medline announced a correction for certain convenience kits that include ICU Medical pain management components containing Huons Bupivacaine Hydrochloride in Dextrose Injection. The FDA classified…
    fda medwatch · 12d agoCRLNegative↗ source
  • FDA issues early alert on non-sterile BD ChloraPrep applicators in Medline convenience kits
    The FDA's Center for Devices and Radiological Health (CDRH) released an early alert about a potential high‑risk issue with certain Medline convenience kits that contain BD ChloraPrep applicators th…
    fda medwatch · 12d agoRegulatoryNeutral↗ 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 · 11d agoRegulatoryNegative↗ source
  • Hardie’s Fresh Foods recalls 5‑lb pepper jalapenos over potential Salmonella contamination
    Dairyland Produce, operating as Hardie’s Fresh Foods in Houston and Dallas, announced a recall of its 5‑pound pepper jalapeno product due to possible Salmonella contamination. The recall affects j…
    fda recalls · 11d 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 · 11d 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 · 11d agoRegulatoryNegative↗ source