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38 stories matching this filter · ← front page

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  • FDA grants accelerated approval to first plasmid DNA immunotherapy for adult recurrent respiratory papillomatosis
    The U.S. Food and Drug Administration granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) as a treatment for adults with recurrent respiratory pa…
    fda press · 9d agoApprovalPositive↗ 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
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Pain766
Nephrology735
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  • FDA clears Edwards' tricuspid valve repair device; Bayer's blood thinner asundexian approved in China
    The U.S. Food and Drug Administration has granted approval for Edwards Lifesciences' new tricuspid valve repair system, expanding treatment options for patients with tricuspid regurgitation. In Ch…
    raps · 14d agoApprovalNeutral↗ 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
  • FDA approves Hibsago, first antisense therapy for chronic hepatitis B
    The U.S. Food and Drug Administration has approved Hibsago (bepirovirsen) injection to be used alongside existing antiviral therapy for chronic hepatitis B virus infection in certain adults without…
    fda press · 19d agoApprovalPositive↗ source
  • FDA expands Anktiva use for BCG-unresponsive high-grade papillary bladder cancer
    The U.S. Food and Drug Administration has broadened the approved use of Anktiva, a therapy given with Bacillus Calmette-Guérin, to treat adults with high-grade papillary-only bladder cancer that ha…
    fda press · 25d agoApprovalPositive↗ 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
  • FDA approves first pediatric heart valve that expands as children grow
    The U.S. Food and Drug Administration has approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for children with congenital pulmonary valve disease. The device is…
    fda press · 1mo agoApprovalPositive↗ source
  • FDA approves Emcitate for peripheral thyrotoxicosis in patients with MCT8 deficiency
    The U.S. Food and Drug Administration announced approval of Emcitate (tiratricol) tablets formulated for oral suspension to treat peripheral thyrotoxicosis in patients with MCT8 deficiency, also ca…
    fda press · 1mo agoApprovalPositive↗ 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
  • FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
    The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known…
    fda press · 1mo agoApprovalPositive↗ 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
  • FDA grants accelerated approval for Etcamah combo therapy for advanced HR-positive, HER2-negative breast cancer
    The U.S. Food and Drug Administration announced accelerated approval of Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for adult patients with hormone-receptor-positive, HER2-negativ…
    fda press · 2mo agoApprovalPositive↗ 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
  • 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 · 2mo 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 · 2mo agoCRLNegative↗ source
  • FDA approves Mimrylo, first hepcidin-mimicking drug for polycythemia vera
    The U.S. Food and Drug Administration announced approval of Mimrylo (rusfertide) for adult patients with polycythemia vera, a rare blood disorder that causes excess red blood cells. The drug mimic…
    fda press · 2mo agoApprovalPositive↗ source
  • FDA greenlights first oral therapy for adult dermatomyositis
    The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets as a treatment for adults with dermatomyositis. Dermatomyositis is a rare autoimmune condition that attacks muscle…
    fda press · 2mo agoApprovalPositive↗ source
  • FDA clears first wearable that continuously tracks both glucose and ketone levels
    The U.S. Food and Drug Administration has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for individuals aged two years and older who have diabetes. The device is…
    fda press · 2mo 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 · 2mo agoRegulatoryNeutral↗ source
  • FDA grants accelerated approval to Genglycos, first therapy for glycogen storage disease type Ia
    The U.S. Food and Drug Administration issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr), marking the first therapy for patients aged eight years and older with glycogen…
    fda press · 2mo agoApprovalPositive↗ source