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128 stories matching this filter · ← front page

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  • Par Health initiates voluntary recall of Argatroban injection after detecting particulate contaminants
    Par Health USA announced a voluntary nationwide recall of its Argatroban Injection 250 mg/2.5 mL product, affecting 22 lots that have been distributed to hospitals and users. The recall was trigge…
    fda recalls · 6d agoRegulatoryNegative↗ source
  • Par Health recalls two lots of Brevital Sodium injection over cellulose particles
    Par Health announced a voluntary recall of two lots of its Brevital® Sodium 500 mg/vial for injection after detecting particulate matter identified as cellulose. The recall is being executed at th…
    fda recalls · 11d agoRegulatoryNegative
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fda medwatch89
globenewswire health73
fda press51
1609
Psychiatry & CNS1100
Ophthalmology840
Endocrinology & Metabolism682
Pain650
Nephrology627
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  • Leader Formulas recalls RAPTURE pre-workout supplement after FDA finds DMAA in product
    Leader Formulas, LLC of Tomball, Texas announced a voluntary nationwide recall of one lot of its RAPTURE pre‑workout powder after testing revealed the presence of the stimulant 1,3‑dimethylamylamin…
    fda recalls · 13d agoCRLNegative↗ source
  • Nova Biomedical issues global correction for StatStrip Glucose Hospital Meter over software patient-ID error
    Nova Biomedical announced a global medical device correction for its StatStrip Glucose Hospital Meter System. The correction targets a software issue in the Gen 2.0 model that can leave prior pati…
    fda recalls · 14d agoCRLNegative↗ source
  • Greenwich Rx voluntarily recalls compounded glutathione injections over possible elevated endotoxin levels
    Greenwich Rx, a 503A compounding pharmacy based in Tomball, Texas, announced a voluntary nationwide recall of specific lots of its compounded glutathione injection product. The recall is being issu…
    fda recalls · 18d agoCRLNegative↗ source
  • White House seeks data on U.S. manufacturing of 86 essential medicines
    The White House Office of Management and Budget has launched a review of domestic production for a list of 86 medicines deemed essential. The request asks manufacturers to provide information on w…
    Endpoints · 21d agoRegulatoryNeutral↗ source
  • Galil Importing Corp recalls Lior ground cinnamon over elevated lead levels
    Galil Importing Corp of Hauppauge, New York announced a recall of its Lior Cinnamon Ground Seasoning because of potential elevated lead contamination. The product, distributed to retail outlets in…
    fda recalls · 25d agoRegulatoryNegative↗ source
  • Roche's Lunsumio clears Phase 3 hurdle, paving way for broader label in indolent lymphoma
    Roche announced that its T cell engager Lunsumio successfully met the primary endpoints in a Phase 3 study of a slow growing blood cancer. The trial, conducted in patients with indolent lymphoma,…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • GSK signs new agreement with China's Chimagen for trispecific T-cell engager targeting blood cancers
    GSK, the UK‑based pharmaceutical company, has entered into a fresh licensing agreement with Chinese biotech Chimagen Biosciences. The partnership focuses on a trispecific T‑cell engager designed fo…
    Endpoints · 1mo agoDealPositive↗ source
  • A&P Creations recalls X10 supplement after discovering undeclared Viagra and Cialis ingredients
    A&P Creations LLC announced a voluntary recall of its X10 Natural Enhancement Supplement after testing revealed the presence of sildenafil and tadalafil, the active ingredients in prescription drug…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • A&P Creations LLC Issues Nationwide Recall of biQ-FEL Due to Undeclared Sildenafil and Tadalafil
    Sildenafil and Tadalafil are active ingredients in FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction. FDA approval of Viagra and Cialis is restrict…
    fda recalls · 1mo ago↗ source
  • Bristol Myers reports Phase 2 success for GPRC5D‑directed CAR‑T therapy
    Bristol Myers announced positive Phase 2 results for its GPRC5D‑directed CAR‑T therapy aimed at treating multiple myeloma. The study demonstrated encouraging efficacy signals, adding to the growing…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • American Regent, Inc. Issues Voluntary Nationwide Recall of Three Lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) Due to the Presence of Particulate Matter and Lack of Assurance of Sterility
    FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) mult…
    fda recalls · 1mo agoRegulatoryNeutral↗ source
  • SUPPLX.com recalls two male sexual-enhancement supplements after FDA finds undeclared yohimbine
    SUPPLX.com announced a voluntary recall of its Business Pill and Branch Manager for Men supplements after FDA laboratory analysis detected undeclared yohimbine in both products. Yohimbine is a pre…
    fda recalls · 1mo agoCRLNegative↗ source
  • Novartis halts CD19 CAR-T trial after three deaths, Bristol Myers also pauses similar program
    Novartis announced a pause to its CD19-directed CAR-T cell therapy trials after three patients experienced fatal immune reactions. The company said the deaths were linked to a severe cytokine relea…
    Endpoints · 1mo agoCRLNegative↗ source
  • FDA clears Protagonist-Takeda therapy for rare blood cancer as Lilly moves to buy Merida for up to $2.88 billion
    The U.S. Food and Drug Administration has granted approval to a collaborative therapy from Protagonist and Takeda aimed at treating a rare form of blood cancer. This regulatory decision adds a new…
    raps · 1mo agoDealPositive↗ source
  • Northwest Naturals recalls frozen cat and dog chicken diets over possible Salmonella and Listeria contamination
    Northwest Naturals of Portland, Oregon announced a voluntary recall of two frozen pet food products after detecting possible bacterial contamination. The recall includes 53 cases (1,272 lb) of fro…
    fda recalls · 1mo agoCRLNegative↗ source
  • FDA greenlights Takeda and Protagonist's rusfertide (Mimrylo) for polycythemia vera
    The U.S. Food and Drug Administration has granted approval to rusfertide, a therapy developed jointly by Takeda Pharmaceutical and Protagonist Therapeutics. The drug, to be marketed under the name…
    Endpoints · 1mo agoApprovalPositive↗ source
  • J&J’s Imaavy gains first-in-class label for warm autoimmune hemolytic anemia
    J&J announced that its monoclonal antibody Imaavy has received a label expansion in the United States. The expanded indication makes Imaavy the first therapy approved specifically for warm autoimm…
    Endpoints · 1mo agoApprovalPositive↗ source
  • FDA clears Roche and Lilly Alzheimer’s blood tests, while Regenxbio gene therapy trial halted again
    The U.S. Food and Drug Administration announced it has granted clearance for blood-based diagnostic tests for Alzheimer’s disease developed by Roche and Eli Lilly. The clearances allow the compani…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA grants approval to Ultragenyx's Genglycos gene therapy for ultra-rare glycogen storage disorder
    Ultragenyx announced that the U.S. Food and Drug Administration has approved its gene therapy called Genglycos. The therapy targets an ultra-rare glycogen storage disorder that can lead to severe…
    Endpoints · 2mo agoApprovalPositive↗ 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 · 2mo agoCRLNegative↗ source
  • Amylyx reports Phase 3 success for avexitide in post-bariatric hypoglycemia
    Amylyx announced a late-stage success for avexitide, a GLP-1 receptor antagonist, in a Phase 3 trial targeting post-bariatric hypoglycemia. The trial results showed the drug achieved its primary e…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • FDA approves Zenbexus for multiple myeloma as NSAI looks to sell MDR notified body unit
    The U.S. Food and Drug Administration has granted approval for Zenbexus to be used in the treatment of multiple myeloma, marking a new therapeutic option for patients with this blood cancer. The a…
    raps · 2mo agoApprovalPositive↗ source
  • ICER finds AstraZeneca’s blood pressure pill Baxfendy not cost-effective at $10,950 a year
    ICER released a report saying the clinical benefits of AstraZeneca’s new blood pressure medication Baxfendy do not justify its listed price. The agency noted the drug is priced at $10,950 per pati…
    Endpoints · 2mo agoRegulatoryNegative↗ source