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  • Lilly leads GLP-1 weight-loss market while Novo Nordisk’s Wegovy exceeds expectations but falls short of forecasts
    Eli Lilly and Novo Nordisk are intensifying their battle for dominance in the multibillion‑dollar GLP‑1 weight‑loss market, with each company promoting its own set of injectable therapies and pipel…
    BioPharma Dive · 12h agoEarningsNeutral↗ source
  • FDA issues early alert on Medical Action epidural kits containing recalled sodium chloride ampules
    The FDA’s Center for Devices and Radiological Health has posted an Early Alert warning about certain epidural kits from Medical Action Industries. The alert notes that the kits include sodium chlor…
    fda medwatch · 19h agoRegulatoryNegative↗ source
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  • Activist Kaos Capital pushes governance overhaul at Capricor ahead of FDA Duchenne decision
    Activist investor Kaos Capital has sent a letter to Capricor Therapeutics shareholders demanding a “governance reset.” The firm asks for a meeting to nominate two independent directors, create an M…
    BioPharma Dive · 10h agoNegative↗ source
  • FDA alerts recall of Medline neonatal heated wire breathing circuits over connector failures
    The FDA's Center for Devices and Radiological Health issued an Early Alert to warn the public about a high‑risk issue with Medline's neonatal and infant heated wire breathing circuits. The problem…
    fda medwatch · 19h agoCRLNegative↗ source
  • Early Alert: Portrait Core Services Software Issue from GE HealthCare
    Patients monitored on Portrait Mobile devices can be discharged (removed) from the Portrait monitoring system during an update to the Portrait Core Services software.
    fda medwatch · 19h agoRegulatoryNeutral↗ source
  • Moderna’s melanoma vaccine trial success sparks $45 billion market value surge
    Moderna’s shares jumped more than 170% after the company announced that its experimental melanoma vaccine, intismeran, met its primary goals in a Phase 3 trial. The surge added roughly $45 billion…
    BioPharma Dive · 1d agoPositive readoutPositive↗ source
  • Ultragenyx secures FDA approval for Glenglycos, first gene therapy for GSD Ia
    Ultragenyx announced FDA approval of Glenglycos, a one-time gene therapy for glycogen storage disease type Ia, a rare genetic disorder. The therapy delivers a functional gene to the liver to resto…
    BioPharma Dive · 1d agoApprovalPositive↗ source
  • Medline recalls convenience kits with B. Braun bupivacaine component, urges correction before use
    Medline has issued a correction for a range of its convenience surgical kits after discovering that they contain components from B. Braun Medical that include bupivacaine hydrochloride in a dextros…
    fda medwatch · 1d agoCRLNegative↗ source
  • Regeneron wins FDA approval for Pasatru, targeting rare bone disease FOP
    The U.S. Food and Drug Administration has approved Regeneron Pharmaceuticals' drug Pasatru for the treatment of fibrodysplasia ossificans progressiva (FOP), a very rare condition in which muscle an…
    BioPharma Dive · 1d agoApprovalPositive↗ source
  • Moderna-Merck mRNA cancer vaccine shows landmark interim success in melanoma trial
    An interim analysis of a Phase 3 trial of an individualized mRNA cancer vaccine from Moderna and Merck showed the treatment met its primary goals. The vaccine, given together with Merck's immunothe…
    BioPharma Dive · 2d agoPositive readoutPositive↗ source
  • B. Braun voluntarily recalls one lot of Excel Lactated Ringers IV solution over particulate contamination
    B. Braun Medical Inc announced a voluntary recall of a specific lot of its Excel Lactated Ringers Injection, a 1000 mL IV solution, after detecting particulate matter in the product. Laboratory an…
    fda recalls · 2d agoCRLNegative↗ source
  • Trump administration eyes Heidi Overton as next FDA commissioner
    President Donald Trump is reported to be preparing a nomination for Heidi Overton to become the next commissioner of the Food and Drug Administration, according to multiple news outlets. Overton i…
    BioPharma Dive · 2d agoRegulatoryNeutral↗ source
  • Optimal Balance Pharmacy recalls one lot of compounded glutathione injection over high endotoxin levels
    Optimal Balance Pharmacy announced a voluntary recall of a single lot of its compounded glutathione 200 mg/mL multi‑dose vials. The recall was triggered after internal testing detected elevated bac…
    fda recalls · 2d agoCRLNegative↗ source
  • Prince Bakery recalls several breads over undeclared milk and sesame allergens
    Prince Bakery Inc. of Bronx, New York announced a recall of multiple Prince brand breads because they may contain undeclared milk or sesame. The recall covers Sesame Italian Bread, Large Italian B…
    fda recalls · 2d agoRegulatoryNegative↗ source
  • AstraZeneca’s Tagrisso plus Orpathys improves survival in MET-mutated lung cancer
    A new combination therapy using AstraZeneca’s Tagrisso together with Hutchmed’s Orpathys has shown a survival benefit for patients with a specific form of non‑small cell lung cancer. The study focu…
    BioPharma Dive · 3d agoPositive readoutPositive↗ source
  • Leo Pharma to acquire experimental rare-skin disease drug dersimelagon in up to $435 million deal
    Leo Pharma announced it will acquire the rights to dersimelagon, an experimental oral therapy currently under FDA review, in a transaction that could total up to $435 million in upfront and near‑te…
    BioPharma Dive · 3d agoDealNeutral↗ source
  • Amylyx reports avexitide cuts severe hypoglycemia by 55% in bariatric surgery patients
    Amylyx Pharmaceuticals announced that its GLP-1 blocker avexitide achieved the primary endpoint in a late‑stage trial, reducing serious to severe hypoglycemic events by 55% compared with placebo in…
    BioPharma Dive · 3d agoPositive readoutPositive↗ source
  • BioMarin to buy Alesta Therapeutics for $275M, adding rare bone disease drug to pipeline
    BioMarin announced Tuesday that it will acquire privately held Alesta Therapeutics, paying $275 million upfront with potential additional payments tied to milestones. The deal, expected to close b…
    BioPharma Dive · 3d agoDealPositive↗ source
  • BD advises recall of sodium chloride ampules in convenience kits after Huons Co. issue
    The FDA issued an Early Alert after Becton Dickinson (BD) sent a letter to customers about a potential high‑risk device issue. The alert concerns convenience kits and procedural trays that contain…
    fda medwatch · 3d agoRegulatoryNegative↗ source
  • Dreyer’s Grand Ice Cream voluntarily recalls select Outshine Fruit Bars over possible glass contamination
    Dreyer’s Grand Ice Cream announced a voluntary recall of certain Outshine Fruit Bars after detecting possible foreign material contamination. The recall includes Strawberry, Watermelon, Grape, Tan…
    fda recalls · 3d agoCRLNegative↗ source
  • L-Nutra recalls Prolon Apulian Almond & Cocoa Spread due to undeclared cashews, pistachios, hazelnuts
    L-Nutra of Culver City, California announced a recall of its Prolon brand Apulian Almond & Cocoa Spread after testing found undeclared tree nut allergens. The affected product is sold in 8.47‑oz (…
    fda recalls · 3d agoRegulatoryNegative↗ source
  • FDA nod is just the first hurdle for Moderna’s potential blockbuster flu vax
    Strain selection timing and mRNA skepticism could limit the impact of Moderna’s game-changing mRNA flu shot.
    BioPharma Dive · 4d agoApprovalPositive↗ source
  • 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 · 4d 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 · 4d agoNegative readoutNegative↗ source
  • 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 · 4d agoNegative readoutNegative↗ source