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  • FDA rejects ITM's radiopharma drug for neuroendocrine tumors over manufacturing issues
    The U.S. Food and Drug Administration has refused to approve a radiopharmaceutical candidate from ITM Isotope Technologies Munich intended for treating neuroendocrine tumors. The agency cited manu…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • Bristol Myers Squibb announces $2.3 billion manufacturing campus in Houston
    Bristol Myers Squibb disclosed plans to build a new manufacturing campus in Houston, Texas, with an estimated cost of $2.3 billion. The campus will expand the company's domestic production capacit…
    Endpoints · 1d agoDealPositive↗ source
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  • Federal judge suspends Pentagon's designation of WuXi AppTec as a Chinese military-linked firm
    A U.S. district judge has temporarily halted the Pentagon’s effort to label WuXi AppTec as a company with ties to the Chinese military. The ruling was issued by Judge James Boasberg, who found the…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • BMS commits $2.3 billion to build modular manufacturing campus in Houston, creating 2,500 jobs
    Bristol Myers Squibb announced a $2.3 billion investment to construct a new manufacturing campus in Houston, Texas. The site will cover about 600,000 square feet and is designed to be modular, allo…
    BioSpace · 1d agoPositive↗ source
  • Sionna Therapeutics reports early-stage cystic fibrosis trial failure, dampening challenge to Vertex
    Sionna Therapeutics said its lead cystic fibrosis drug did not meet primary endpoints in an early-stage study, marking a setback for the company. The result reduces expectations that Sionna could…
    Endpoints · 1d agoNegative readoutNegative↗ source
  • Sionna’s Phase 2a CF trial fails, shares plunge as Vertex’s Trikafta remains standard of care
    Sionna Therapeutics announced that its Phase 2a cystic fibrosis trial of the NBD1 stabilizer SION-719 did not meet its primary endpoint, sending the company’s stock down more than 90% in pre‑market…
    BioSpace · 1d agoNegative readoutNegative↗ source
  • Psychedelic firms Definium and Compass poised for key data releases
    Investors and analysts are focusing on two psychedelic companies as they approach pivotal milestones. Definium Therapeutics is set to release Phase 3 Voyage data for its single-dose oral LSD candi…
    BioSpace · 1d agoPositive readoutPositive↗ source
  • AstraZeneca and CSPC launch joint venture to build biologics plant in Shijiazhuang
    AstraZeneca and China's CSPC Pharmaceutical have formed a joint venture to construct a biologics manufacturing facility in Shijiazhuang. The agreement follows AstraZeneca's pledge earlier this year…
    BioSpace · 1d agoDealPositive↗ source
  • Silence Therapeutics moves siRNA drug for polycythemia vera to Phase 3 after Phase 2 success
    Silence Therapeutics announced that its siRNA candidate divesiran achieved its primary endpoint in a Phase 2 study in patients with polycythemia vera, a rare blood cancer. The trial results showed…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • BioMarin drops BMN 401 after Phase 3 trial misses clinical endpoints, ending $270M Inozyme asset
    BioMarin announced it will stop development of BMN 401, an enzyme replacement therapy acquired in its $270 million purchase of Inozyme Pharma. The decision follows the Phase 3 ENERGY trial in pati…
    BioSpace · 1d agoNegative readoutNegative↗ source
  • 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 · 1d 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 · 1d agoNegative↗ source
  • FDA issues warning letters to Indian OTC drugmaker over falsified logbooks and cites GMP lapses at two other firms
    The FDA sent warning letters to an over‑the‑counter drug manufacturer in India after discovering the company had submitted falsified production logbooks. The agency also cited two additional OTC m…
    raps · 1d agoRegulatoryNegative↗ source
  • FDA issues warning letters to Indian OTC drugmaker for falsified logbooks and to two others for GMP testing lapses
    The U.S. Food and Drug Administration sent a warning letter to an over‑the‑counter drugmaker in India after discovering that the company had submitted falsified logbooks to the agency. In addition…
    raps · 1d agoRegulatoryNegative↗ 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 · 1d agoDealPositive↗ 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 · 1d 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 · 1d agoDealPositive↗ source
  • India tightens penalties for submitting false regulatory documents
    The Indian government has introduced stricter penalties for applicants who submit misleading, fake, or fabricated documents to regulatory authorities, prohibiting them from making further filing re…
    raps · 1d agoRegulatoryNeutral↗ 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 · 1d 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 · 1d agoPositive readoutPositive↗ 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 · 1d agoNeutral↗ 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 · 1d agoNeutral↗ 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 · 3d 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 · 4d 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 · 4d agoRegulatoryNeutral↗ source