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1,925 stories matching this filter · ← front page

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  • Global Ebola preparedness fixated on one strain, leaving gaps for other species
    Krutika Kuppalli, a former WHO medical officer, and virologist Placide Mbala write that the world’s readiness for Ebola has been narrowly focused. They draw on Kuppalli’s experience in the 2014‑201…
    STAT · 15h agoNegative↗ source
  • China clamps down on investigator-initiated clinical trials, tightening oversight
    China has announced tighter oversight of investigator-initiated trials (ITTs), requiring these studies to obtain approval from the National Medical Products Administration before they can begin. Th…
    STAT · 15h agoRegulatoryNeutral↗ source
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  • AGC Biologics targets in-vivo gene therapies with stable producer lines and next-gen purification
    The industry is moving from ex vivo to in vivo gene delivery, a change that forces viral vector manufacturers to rethink scale, purity, cell lines and analytical methods. In in vivo approaches the…
    BioSpace · 16h agoPositive↗ source
  • BMS's Cobenfy faces market hurdles as side effects limit uptake, MapLight eyes opportunity
    The FDA approved Bristol Myers Squibb's Cobenfy in 2024, marking the first novel schizophrenia treatment in 35 years and raising hopes for a new therapeutic approach. Since its launch, the drug ha…
    BioSpace · 19h agoNegative↗ source
  • RevMed partners with BeOne for Asian rights to RAS drugs as MoonLake reports Phase 3 success
    RevMed and BeOne have entered a partnership granting BeOne rights to commercialize RevMed’s RAS pathway drugs in selected Asian markets. The agreement also includes collaboration on upcoming clini…
    Endpoints · 8h agoDealPositive↗ source
  • FDA to require companies to notify agency of new food additives, creating public database
    The Health and Human Services Department announced a new policy that obligates manufacturers to inform the FDA when they introduce a new substance into human or animal food, and to explain how they…
    STAT · 8h agoRegulatoryNeutral↗ source
  • Calls to Ban Prior Authorizations Amid Hospital Job Cuts Highlight Health‑Care Policy Debate
    The Health Care Inc. newsletter from STAT highlighted a proposal to eliminate most prior authorizations, a requirement that insurers use to control drug spending. The suggestion comes from policy…
    STAT · 8h agoNeutral↗ source
  • Latigo and BlossomHill file Nasdaq IPO plans to fund pain and cancer pipelines
    Latigo Biotherapeutics and BlossomHill Therapeutics, both based in California, have filed applications to list on the Nasdaq Global Select Market. Latigo aims to raise up to $285.2 million to advan…
    BioSpace · 11h agoDealNeutral↗ source
  • BioNTech veteran secures $25M seed round for virtual cancer surveillance startup
    A new virtual cancer surveillance company has closed a $25 million seed round, with the funding led by investors attracted to its novel approach to monitoring tumors. The company is headed by Ryan…
    Endpoints · 12h agoDealPositive↗ source
  • 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 · 6h 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 · 13h agoPositive readoutPositive↗ source
  • 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 · 15h agoNeutral↗ source
  • Aspo Oyj announces upcoming leadership changes scheduled for August 10, 2026
    Aspo Oyj, a Finnish specialty chemicals company, issued a brief notice indicating that it will implement leadership transactions. The announcement specifies that the changes will take effect on Au…
    globenewswire health · 9h 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 · 9h agoLayoffsNegative↗ source
  • Aspo Plc reports managers' transactions on August 10, 2026
    Aspo Plc disclosed that its managers executed transactions on August 10, 2026, as recorded in a filing. The filing does not provide details about the nature, size, or parties involved in the trans…
    globenewswire health · 9h agoNeutral↗ 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 · 15h 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 · 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