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2,047 stories matching this filter · ← front page

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  • Scholar Rock removes Indiana manufacturing site from SMA drug application after FDA cites deficiencies
    Scholar Rock, a Massachusetts biotech, announced it is withdrawing an Indiana manufacturing facility from its filing for a prospective spinal muscular atrophy (SMA) therapy. The decision follows a…
    Endpoints · 1h agoRegulatoryNegative↗ source
  • Denali Therapeutics' Avlayah generates $3.6M in Q1, beating forecasts
    Denali Therapeutics reported that its newly launched Hunter syndrome therapy Avlayah earned $3.6 million in revenue during the first quarter after its April market entry. Analysts had projected ro…
    BioSpace · 8h agoPositive readoutPositive↗ source
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  • States urged to use low-cost, scalable outreach for Medicaid enrollees facing 2027 eligibility changes
    States must begin notifying Medicaid beneficiaries about upcoming eligibility changes by September, as required by the One Big Beautiful Bill Act of 2025. The changes, set to take effect in 2027, i…
    STAT · 10h agoNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 4h agoLayoffsNegative↗ source
  • STAT+: Ban prior auth? And hospitals cut jobs
    We examine a call to reform how health insurers do business, and a look at the impact of 340B restrictions.
    STAT · 4h ago↗ source
  • Sionna’s cystic fibrosis failure is a windfall for Vertex’s blockbuster franchise
    A surprise flop in Phase 2a cystic fibrosis trial sent Sionna’s shares plummeting, but for Vertex, the news reinforced its standard-of-care standing with highly successful drugs like Trikafta.
    BioSpace · 4h ago↗ source
  • STAT+: FDA panel to weigh Grail’s Galleri test
    China reins in its biotech innovation engine, radiopharma boom meets unexpected hurdles, and more news from The Readout
    STAT · 4h ago↗ source
  • Jazz commits up to $1.3B to buy Actio, bolster epilepsy pipeline
    Jazz Pharmaceuticals is reaching into its wallet once again, this time buying Actio Biosciences and an experimental therapy for KCNT1+ epilepsy, a form of the disease with no FDA-approved treatments.
    BioSpace · 4h ago↗ source
  • Aspo Oyj - Johdon liiketoimet
    Aspo Oyj Johtohenkilöiden liiketoimet 10.8.2026 klo 17.30
    globenewswire health · 4h ago↗ source
  • Aspo Plc - Managers' Transactions
    Aspo Plc Managers’ transactions August 10, 2026 at 17.30 EET
    globenewswire health · 4h ago↗ source
  • Jazz bets on epilepsy again by acquiring Actio for $820M upfront
    Jazz Pharmaceuticals will buy Actio Biosciences for $820 million upfront and up to $500 million more if certain milestones are met for its ultra-rare epilepsy drug. The deal further solidifies Jazz…
    Endpoints · 5h ago↗ source
  • STAT+: Pharmalittle: We’re reading about a Sanofi drug shortage, a Jazz Pharma deal, and more
    Sanofi is experiencing shortages of two medicines used to treat Pompe disease after the FDA warned the company over manufacturing issues
    STAT · 5h ago↗ source
  • Opinion: We prepared for Ebola — but not this Ebola
    “Preparedness cannot mean optimizing every investment for yesterday's epidemic,” write Krutika Kuppalli and Placide Mbala.
    STAT · 10h ago↗ source
  • Sanofi reports shortages of Myozyme and Nexviazyme for Pompe disease after FDA manufacturing warning
    Sanofi has warned that supplies of two medicines used to treat Pompe disease are running low. The company notified patient groups and physicians in the United States and Europe that the shortage af…
    STAT · 19h agoRegulatoryNegative↗ source
  • Taylor Fresh Foods recalls jalapeño-containing products over possible Salmonella contamination
    Taylor Fresh Foods announced a recall of finished products that contain jalapeño peppers after being notified of a voluntary recall by Coast Citrus Distributors due to potential Salmonella contamin…
    fda recalls · 1d agoRegulatoryNegative↗ source
  • Weekly roundup: Experts debate China biotech work ethic and a stalled megamerger
    The Endpoints News team hosted a panel of industry experts in Cambridge, Massachusetts, to examine the future of biotech in China. Participants highlighted concerns about the country’s work ethic a…
    Endpoints · 2d agoNeutral↗ source
  • Replimune secures FDA approval for Tudriqev, eyes $1.3 bn peak sales in advanced melanoma
    Replimune announced FDA approval of its therapy Tudriqev for patients with advanced melanoma who have progressed after PD-1 treatment. Analysts at BMO Capital Markets project the drug could genera…
    BioSpace · 3d agoApprovalPositive↗ source
  • Replimune secures FDA accelerated approval for melanoma therapy Tudriqev
    Replimune announced that the FDA has granted accelerated approval to its melanoma therapy RP1, marketed as Tudriqev, after two earlier rejections and a third expedited review. The decision reflects…
    STAT · 3d agoApprovalPositive↗ source
  • Senate introduces BINSA bill to tighten review of China biotech and pharma transactions
    The U.S. Senate has introduced the Biotech Innovation and National Security Act (BINSA), a bill that would tighten oversight of biotech and pharmaceutical transactions involving China. The proposa…
    Endpoints · 3d agoRegulatoryNeutral↗ source
  • FDA schedules September advisory panel to review Grail's cancer test after trial miss
    The FDA announced it will hold an advisory committee meeting in September to examine Grail's multi‑cancer early detection test. The test recently failed to meet its primary endpoint in a large, ra…
    Endpoints · 3d agoRegulatoryNeutral↗ source
  • Biopharma job postings rise 15% in Q2 as layoffs fall and M&A activity picks up
    The Q2 2026 BioSpace report shows a strengthening biopharma job market, with more openings and fewer layoffs compared with the prior year. Job postings on BioSpace were up 15% year-over-year and 1…
    BioSpace · 3d agoPositive↗ source
  • Intellia identifies HLA allele linked to severe liver enzyme spikes in ATTR gene therapy
    In November 2025, a patient died after receiving Intellia Therapeutics' investigational gene silencer for transthyretin amyloidosis, prompting a safety review of the company’s ATTR gene therapy pro…
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • BlossomHill and Latigo close IPO week with $496 million raised
    BlossomHill Therapeutics, a cancer‑focused biotech, completed its initial public offering this week. Latigo, a company developing non‑opioid pain treatments, also went public at the same time. To…
    Endpoints · 3d agoDealPositive↗ source
  • Active shooter incident forces CDC staff to shelter in place, highlighting ongoing threats to public health workers
    On August 8, 2025, the author was working in an office at the Centers for Disease Control and Prevention when a series of loud bangs sounded outside. A laboratory director reported that a neighbori…
    STAT · 3d agoNegative↗ source
  • NIH to restrict Pathways to Independence grants to U.S. citizens and permanent residents
    The National Institutes of Health announced plans to limit eligibility for its “Pathways to Independence” award to U.S. citizens, permanent residents, and non‑citizen nationals. The change would ba…
    STAT · 3d agoRegulatoryNegative↗ source