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  • Overdose deaths fall sharply in US and abroad, report links decline to naloxone and harm-reduction measures
    A new report highlights a sudden drop in drug overdose deaths after years of consistently high numbers in the United States. The data show that U.S. deaths fell 27% in 2024 and preliminary figures…
    STAT · 2mo agoNeutral↗ source
  • FDA grants emergency use authorization for Capstar and generic nitenpyram to prevent and treat New World screwworm in dogs and cats
    The U.S. Food and Drug Administration issued an Emergency Use Authorization for Capstar (nitenpyram) tablets and updated the EUA for the generic Nitenpyram Tablets. Both products are now authorized…
    fda press · 2mo agoRegulatoryPositive↗ source
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  • FDA’s Biologics Branch Scores Wins Against Unproven Stem Cell Clinics, Says Expert
    Professor Paul Knoepfler, a cell‑biology professor at UC Davis, writes that the FDA’s biologics division has recently taken concrete steps to curb the proliferation of unproven stem‑cell clinics in…
    STAT · 2mo agoRegulatoryPositive↗ source
  • FDA launches TEMPO pilot to let generative AI medical devices reach patients before formal approval
    The Food and Drug Administration has opened a new pilot program called TEMPO that permits certain generative‑AI medical devices to be made available to patients even though they have not received f…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • FDA advisory panels for Capricor and Replimune highlight need for rare-disease specialist input
    Recent FDA advisory committee meetings reviewing therapies from Capricor Therapeutics and Replimune produced markedly different outcomes, underscoring how the agency’s reliance on specialist input…
    BioSpace · 2mo agoRegulatoryNegative↗ 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
  • New cardiovascular guidelines released for tactical athletes such as EMTs, firefighters and police
    The American College of Cardiology and the American Heart Association issued new cardiovascular guidance aimed at clinicians who treat "tactical athletes," a term that includes emergency responders…
    STAT · 2mo agoRegulatoryPositive↗ source
  • OpenEvidence introduces new family of AI models for health tech
    OpenEvidence announced a new family of artificial intelligence models aimed at health technology applications, as reported in STAT's Health Tech newsletter. The announcement highlights the company'…
    STAT · 2mo agoPositive↗ source
  • Benelux biotech strength hampered by fragmented investment, experts discuss path to unified corridor
    In a recent episode of BioSpace's "Denatured" podcast, host Jennifer C. Smith-Parker talks with Christina Takke of V-Bio Ventures and Mariette van der Velden‑Roesink of Curie Capital about the biot…
    BioSpace · 2mo agoNeutral↗ source
  • Fi recalls dog supplements over possible Salmonella contamination
    Fi, a New York-based company, announced a recall of its dog supplement products due to potential Salmonella contamination linked to an ingredient supplied to its manufacturer. The manufacturer has…
    fda recalls · 2mo agoCRLNegative↗ source
  • Fauci warns of public "selective amnesia" on Covid, hints at upcoming book as STAT newsletter covers Trump drug pricing deals
    STAT's twice‑weekly D.C. Diagnosis newsletter continues to blend health policy analysis with behind‑the‑scenes commentary, offering readers insight into current political debates. In a recent inte…
    STAT · 2mo agoNeutral↗ source
  • HHS reverses stance on disability lawsuit amid reports of falling overdose deaths and AI device access
    The Department of Health and Human Services has changed its position on a pending disability lawsuit, signaling a shift in its legal strategy. Data released this year show a sharp decline in U.S.…
    STAT · 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
  • Pediatricians Offer 'Last Resort' Care for Vaccine-Skeptical Parents
    A small group of pediatricians across six states have created what they call a "practice of last resort" for families hesitant about vaccines. Rather than turning patients away, they focus on liste…
    STAT · 2mo agoNeutral↗ source
  • Former doula turned OB‑GYN calls for better understanding between the two professions
    Debra Eluobaju, a maternal‑fetal medicine fellow who previously worked as a doula, reflects on the gap between doulas and obstetricians. She argues that many conflicts in maternity care stem from s…
    STAT · 2mo agoNeutral↗ source
  • Novartis and BMS pause CAR‑T trials after patient deaths while Revolution Medicines gains early FDA approval for pancreatic cancer drug
    Novartis has placed several trials of its CAR‑T therapy rapcabtagene autoleucel on hold after three patients receiving the treatment died. Bristol Myers Squibb also voluntarily froze its autoimmun…
    BioSpace · 2mo agoRegulatoryNeutral↗ source
  • BMS faces steep risk if milvexian trial fails, could spark mega-cap merger frenzy
    BMS is heading toward a readout for its oral FXIa inhibitor milvexian, a trial that analysts say could be pivotal for the company's future growth. The recent collapse of merger talks with AstraZen…
    BioSpace · 2mo agoNegative readoutNegative↗ source
  • FDA to tighten oversight of foreign clinical trial sites as China trial volume soars
    FDA officials wrote an editorial stating that inspection access is not an administrative footnote and announced plans to expand oversight of foreign clinical trial sites. The initiative follows th…
    BioSpace · 2mo agoRegulatoryNeutral↗ source
  • Beyond GLP-1s: Companies eye new obesity drug mechanisms as efficacy plateaus
    The obesity drug market continues to expand, with GLP-1 therapies growing from about $5.5 billion in 2023 to over $55 billion projected for 2033. These agents are used for weight loss, diabetes and…
    BioSpace · 2mo agoNeutral↗ source
  • Ultragenyx's Angelman syndrome drug fails in Phase 3 trial, showing no benefit
    Ultragenyx announced that its experimental therapy GTX-102 for Angelman syndrome did not demonstrate any benefit compared with a sham control in a large Phase 3 trial. The drug had previously show…
    STAT · 2mo agoNegative readoutNegative↗ source
  • UniQure submits FDA and UK applications for first Huntington’s disease gene therapy
    UniQure has filed a biologics license application (BLA) with the U.S. FDA and a separate submission with the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its experimental gene…
    BioSpace · 2mo agoRegulatoryNeutral↗ source
  • UK regulator suspends new patients from receiving Tavneos (Avacopan Vifor) amid data concerns
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has decided to stop prescribing Tavneos, known locally as Avacopan Vifor, to any new patients. The decision follows the regulator’…
    BioSpace · 2mo agoRegulatoryNegative↗ source
  • UniQure submits experimental Huntington's gene therapy to FDA for accelerated review
    UniQure announced that it has filed its experimental gene therapy for Huntington's disease with the U.S. Food and Drug Administration, seeking accelerated approval. The submission follows earlier…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Novartis’ BTK inhibitor remibrutinib cuts MS relapse rates in Phase 3, setting up FDA filing
    Novartis reported that its BTK inhibitor remibrutinib, already approved for chronic spontaneous urticaria, lowered annualized relapse rates in two Phase 3 studies of relapsing multiple sclerosis wh…
    BioSpace · 2mo agoPositive readoutPositive↗ source
  • Trump’s new pharma deals lower Medicaid prices but shield Medicare from cuts
    Washington officials announced new voluntary pricing agreements with several midsize biotechnology companies. The deals require the firms to reduce the prices they charge under Medicaid, the progra…
    STAT · 2mo agoDealNegative↗ source