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47 stories matching this filter · ← front page

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  • Alethio Therapeutics raises $90 million Series A to develop antibody for essential thrombocythemia
    Alethio Therapeutics, a spinout from the University of Oxford, announced a $90 million Series A financing round. The capital will fund the company’s lead program, an antibody designed to treat ess…
    Endpoints · 4d agoDealPositive↗ source
  • New treatments for preeclampsia move closer to patients
    Emily Chaddock’s experience highlights the danger of severe preeclampsia, a pregnancy complication that can threaten both mother and baby. At 27 weeks she developed the condition, leading to a rapi…
    Endpoints · 3d agoPositive↗ source
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fda medwatch103
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  • First wave of ASH 2026 abstracts released, featuring data from J&J, Servier and AstraZeneca
    The American Society of Hematology’s annual meeting is set for New Orleans, Louisiana, a little over a month away. The first batch of abstracts for the conference has been posted, showcasing early…
    Endpoints · 4d agoNeutral↗ source
  • Karyopharm Therapeutics to merge with Ayrmid as it enters bankruptcy
    Karyopharm Therapeutics, a commercial-stage biotech focused on blood cancers, announced it will pursue a merger with Ayrmid while navigating a bankruptcy process. The move aims to combine the two c…
    Endpoints · 6d agoDealNeutral↗ source
  • Dren Bio secures $350 million to advance blood-cancer therapy toward 2027 launch
    Dren Bio, a California biotech firm, announced it has closed a financing round that raised $350 million. The funding will be directed toward developing its lead blood‑cancer drug, with the company…
    Endpoints · 10d agoDealPositive↗ source
  • SLR Food Distribution recalls Wise Wife ground cinnamon over possible lead contamination
    SLR Food Distribution Inc., based in Hicksville, New York, announced a voluntary recall of its Wise Wife brand ground cinnamon. The recall was issued because the product may be contaminated with e…
    fda recalls · 10d agoRegulatoryNegative↗ source
  • Tonight We Ride recalls Ultimate Forza male supplement after finding undeclared sildenafil, tadalafil and dapoxetine
    Tonight We Ride, LLC of Lakeville, Minnesota announced a voluntary recall of its Ultimate Forza male supplement capsules. The recall was triggered after testing revealed the product contains undec…
    fda recalls · 15d agoCRLNegative↗ source
  • Pfizer halts Phase 2 trial of PF-06835375 in primary immune thrombocytopenia
    Pfizer announced that it is stopping its Phase 2 study of the experimental program PF-06835375, which was being evaluated in patients with primary immune thrombocytopenia, a rare autoimmune blood d…
    Endpoints · 19d agoNegative readoutNegative↗ source
  • 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 · 26d 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 · 1mo agoRegulatoryNegative↗ source
  • 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 · 1mo 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 · 1mo 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 · 1mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo agoCRLNegative↗ 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 · 2mo 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 · 2mo 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 · 2mo agoApprovalPositive↗ 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