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685 stories matching this filter · ← front page

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  • Eros Apothecary recalls Candy Power For Man honey supplement after undisclosed tadalafil found
    Eros Apothecary of Indio, California announced a recall of its Candy Power For Man Organic Honey dietary supplement after FDA testing revealed the presence of undeclared tadalafil. Tadalafil is th…
    fda recalls · 5h agoCRLNegative↗ source
  • Game Changer Products recalls 10 Day Forecast capsules after FDA finds undeclared sildenafil and acetaminophen
    Game Changer Products LLC announced a voluntary nationwide recall of its 10 Day Forecast capsules, a dietary supplement marketed at 3200 mg. The FDA’s analysis detected the presence of undeclared…
    fda recalls · 4h agoCRLNegative
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globenewswire health73
fda press59
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Psychiatry & CNS1211
Ophthalmology1074
Endocrinology & Metabolism782
Pain780
Nephrology764
↗ source
  • FDA releases draft guidance for early-phase first-in-human studies of solid-tumor therapies
    The U.S. Food and Drug Administration has issued draft guidance to help sponsors design early-phase first-in-human IND studies for investigational drugs and biologics targeting solid tumors. The g…
    raps · 1d agoRegulatoryNeutral↗ source
  • Intersurgical pulls 22mm smoothbore breathing tubes after FDA warns of detaching connectors
    The FDA Center for Devices and Radiological Health issued an early alert about a potentially high‑risk issue with certain Intersurgical breathing devices. Intersurgical has sent a letter to custom…
    fda medwatch · 2d agoRegulatoryNegative↗ source
  • FDA issues early alert as Arrow International recalls guidewires with spring wire guide components
    The FDA's Center for Devices and Radiological Health has issued an early alert about a potential high‑risk issue with certain Arrow International guidewire products that contain spring wire guide c…
    fda medwatch · 2d agoRegulatoryNeutral↗ source
  • Acting FDA commissioner reports strong public interest in new expedited IND pilot
    Acting FDA Commissioner Kyle Diamantas told attendees at the Friends of Cancer Research annual meeting that the agency’s newly launched Expedited IND pilot has attracted considerable public attenti…
    raps · 2d agoRegulatoryPositive↗ source
  • Laub’s Feeding & Cubing voluntarily recalls 89 tons of mini hay cubes over botulism risk
    Laub’s Feeding & Cubing, Inc. of Beryl, Utah announced a voluntary recall of its Grade A Mini Hay Cubes. The recall covers up to 89 tons of product sold between Oct 3 and Oct 31, 2026 after the co…
    fda recalls · 2d agoCRLNegative↗ source
  • Experts urge pharma firms to build regulatory intelligence before laws take effect
    Regulatory specialists advise companies not to wait for legislation to be finalized before creating a regulatory intelligence framework. They argue that early preparation helps firms stay ahead of…
    raps · 2d agoRegulatoryNeutral↗ source
  • Family Farmstead Dairy recalls all cheddar cheese over possible Listeria contamination
    Family Farmstead Dairy announced a recall of all its cheddar cheese products because they may be contaminated with Listeria monocytogenes. Listeria can cause serious infections, especially in youn…
    fda recalls · 2d agoRegulatoryNegative↗ source
  • Recon: Bayer wins FDA approval for stroke prevention drug; Third Rock enters $2B partnership with AI-focused Chinese biotech
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 2d ago↗ source
  • FDA Approves First Factor Xla Inhibitor to Help Prevent Stroke in Certain Adults at High Risk
    FDA today approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa (FXIa) inhibitor for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a rec…
    fda press · 2d agoApprovalPositive↗ source
  • FDA orders label warnings for GLP-1 drugs over rare eye-loss risk
    The U.S. Food and Drug Administration has issued a safety communication that requires all glucagon-like peptide-1 receptor agonist (GLP-1 RA) products to add new warnings to their labeling. The ad…
    fda medwatch · 3d agoRegulatoryNegative↗ source
  • Abiomed issues recall of Automated Impella Controllers due to safety risk
    Abiomed has announced a recall of certain Automated Impella Controllers (AIC) after a review of service records. The FDA classified the recall as the most serious type, warning that continued use…
    fda medwatch · 3d agoCRLNegative↗ source
  • India moves to suspend licenses of firms making substandard medicines
    The Indian government has proposed a rule that would immediately suspend the manufacturing licence of any company whose drug fails to meet quality standards. The initiative is intended to boost dr…
    raps · 3d agoRegulatoryNeutral↗ source
  • FDA cuts required analytical tests for emergency-use diagnostic devices in new guidance
    On 9 November 2026 the U.S. Food and Drug Administration released final guidance aimed at simplifying validation of in-vitro diagnostic devices used in public-health emergencies. The document outli…
    raps · 3d agoRegulatoryPositive↗ source
  • FDA reduces required analytical tests for emergency-use diagnostic devices
    The FDA finalized new guidance aimed at streamlining validation for in-vitro diagnostic (IVD) devices that detect emerging pathogens during public-health emergencies. The guidance lowers the numbe…
    raps · 3d agoRegulatoryNeutral↗ source
  • Cardinal Health updates use instructions for Presource kits with BD Alaris infusion sets
    Cardinal Health has sent a letter to customers updating the use instructions for its Presource convenience kits that contain BD Alaris pump infusion sets. The update does not call for removal of t…
    fda medwatch · 3d agoCRLNeutral↗ source
  • Recon: FDA orders new eye risk warnings for Ozempic, Zepbound; FDA launches investigation of Novartis’ Zolgensma after cancer ca...
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 3d ago↗ source
  • Fresh & Ready Foods recalls 2,414 Fresh To You sausage, egg & cheese biscuit sandwiches over possible Listeria contamination
    Fresh & Ready Foods LLC of Renton, Washington announced a recall of 2,414 Fresh To You sausage, egg and cheese biscuit sandwiches after testing indicated a potential contamination with Listeria mon…
    fda recalls · 4d agoNegative↗ source
  • FDA probes cancer risk from Zolgensma gene therapy after post-marketing tumor reports
    The FDA has issued a safety communication indicating it is investigating reports of malignancies in patients treated with Zolgensma, the adeno‑associated virus gene therapy for spinal muscular atro…
    fda medwatch · 6d agoRegulatoryNegative↗ source
  • Regulators urge risk-based lifecycle approach for AI tools amid election-linked FDA uncertainty
    A panel of regulatory experts at the RAPS AI in Regulatory Conference in Barcelona urged professionals using AI tools to adopt a risk-based, life-cycle perspective rather than focusing solely on va…
    raps · 6d agoRegulatoryNeutral↗ source
  • Eugia US recalls specific lot of vancomycin injection after glass particle found in vials
    Eugia US LLC, formerly Auro Medics Pharma, announced a voluntary nationwide recall of the vancomycin hydrochloride injection (1.25 g per 30 mL vial) for lot number 3VM26026A. The recall was trigge…
    fda recalls · 6d agoCRLNegative↗ source
  • Regulatory experts urge risk-based, lifecycle validation for AI tools in FDA work
    At the RAPS AI in Regulatory Conference in Barcelona, a panel of experts discussed the growing use of AI tools by regulatory professionals. They recommended a risk-based, lifecycle approach to val…
    raps · 6d agoRegulatoryNeutral↗ source
  • FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancer
    The U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
    fda press · 6d agoApprovalPositive↗ source
  • MDCG issues guidance on clinical evidence for orphan in-vitro diagnostics
    The Medical Device Coordination Group (MDCG) has published new guidance that explains how clinical evidence requirements apply to orphan in-vitro diagnostics (IVDs). The document is intended to he…
    raps · 7d agoRegulatoryNeutral↗ source