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1,204 stories matching this filter · ← front page

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  • Hims & Hers says it can quickly launch six wellness peptides if FDA lifts ban
    Hims & Hers used its second‑quarter earnings call to explain that it is preparing to offer six consumer wellness peptides that are currently prohibited for compounding pharmacies. The company says…
    Endpoints · 1h agoRegulatoryPositive↗ source
  • Former Legend Biotech chief Ying Huang named CEO of K2, targets $250 million Series A to license Asian assets
    Ying Huang spent the past seven years building one of the leading cancer cell‑therapy companies before stepping down as CEO of Legend Biotech. Weeks after announcing his departure, Huang has taken…
    Endpoints · 2h agoDealPositive↗ source
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  • Swiss startup Vaderis raises $152 million to fund Phase 3 trial of rare bleeding disorder therapy
    Vaderis Therapeutics, a 13‑person Swiss biotech, announced a $152 million Series B financing round aimed at advancing its experimental therapy into a Phase 3 study. The company is testing a treatm…
    Endpoints · 3h agoDealPositive↗ source
  • Epicrispr secures $90M after early data on epigenetic FSHD treatment
    Epicrispr Biotechnologies has raised $90 million for its Series C round after sharing promising early data around a potential new way to treat a rare muscle disease called facioscapulohumeral muscu…
    Endpoints · 1h ago↗ source
  • Zydus’ Sentynl pens $475M deal for Mereo’s phase 3-ready rare genetic lung disease drug
    Sentynl Therapeutics has penned a deal potentially worth $475 million for the option to market Mereo BioPharma's phase 3-ready rare genetic respiratory disease drug in the U.S.
    Fierce Biotech · 5h ago↗ source
  • Aura lays off 20% of workforce, rejigs C-suite amid R&D refocus on eye cancer
    Aura Biosciences is refocusing under its recently installed CEO, laying off 20% of its employees and overhauling its C-suite as it narrows its focus on ocular oncology.
    Fierce Biotech · 6h ago↗ source
  • Abbott teams with Google Health on AI-powered health insights app
    Two giants of their respective fields, Abbott and Google, are joining forces for a first-of-its-kind team-up that aims to build out a digital picture of people’s health.
    Fierce Biotech · 11h ago↗ source
  • FDA issues early alert after BD needle set defects linked to four deaths
    The FDA’s Center for Devices and Radiological Health released an early alert warning clinicians to stop using Becton Dickinson’s intraosseous vascular access needle sets after reports of serious in…
    Fierce Biotech · 1d agoRegulatoryNegative↗ source
  • Sionna’s cystic fibrosis flop sends stock down 90%, but a ‘significant positive’ for Vertex
    Sionna Therapeutics has axed a cystic fibrosis add-on program after flunking a phase 2 trial, eliminating a would-be challenger to Vertex Pharmaceuticals’ empire. The biotech plans to “take actions…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • AbCellera's Phase 2 hot flash trial beats aggressive upside target, challenging Astellas and Bayer
    AbCellera announced that its Phase 2 study of ABCL635, an antibody that blocks the NK3R receptor, met its primary endpoint in postmenopausal women with hot flashes. The trial enrolled 92 participan…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • AbCellera reports striking Phase 2 results for hot-flash treatment, shares jump 31%
    AbCellera Biologics announced positive Phase 2 data for its neurokinin-3 receptor antagonist aimed at relieving vasomotor symptoms such as hot flashes. The company described the results as strikin…
    Endpoints · 23h agoPositive readoutPositive↗ source
  • Jazz Pharmaceuticals to acquire Actio Biosciences for $820 million upfront, targeting ultra-rare epilepsy
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences, a company developing an ultra‑rare epilepsy therapy. The transaction includes an upfront cash payment of $820 million, with the p…
    Endpoints · 1d agoDealPositive↗ source
  • Jazz Pharma to acquire Actio Biosciences for $820M, adding KCNT1+ epilepsy drug to its pipeline
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences for an upfront payment of $820 million, expanding its portfolio of epilepsy medicines. The deal brings Actio’s lead candidate, ABS…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Silence Therapeutics’ Phase 2 Trial Shows Strong Efficacy of divesiran in Polycythemia Vera
    Silence Therapeutics reported that its siRNA candidate divesiran met the primary endpoint in a phase 2 study of patients with polycythemia vera. The trial enrolled 48 participants and 88% of those…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • BMS to build $2.3 B Houston plant as MHRA clears Lilly's weight-loss drug; IMDRF issues PCCP guidance
    Bristol Myers Squibb announced a plan to invest about $2.3 billion in a new manufacturing facility in Houston. The site is expected to expand the company’s production capacity for its pipeline and…
    raps · 1d agoRegulatoryNeutral↗ source
  • Trump orders MMR vaccine to be administered as three separate shots, citing autism concerns
    President Donald Trump announced via an executive order that the combined measles, mumps and rubella (MMR) vaccine should be split into three individual injections for children. He claimed the cha…
    Endpoints · 18h agoRegulatoryNegative↗ source
  • 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 · 19h 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 · 20h agoDealPositive↗ source
  • 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 · 21h agoRegulatoryNeutral↗ 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 · 23h agoNegative readoutNegative↗ 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
  • FDA issues complete response letter rejecting ITM’s neuroendocrine tumor drug over manufacturing concerns
    The U.S. Food and Drug Administration sent a complete response letter to ITM Isotopes Technologies, refusing approval of its lead candidate for gastroenteropancreatic neuroendocrine tumors because…
    Fierce Biotech · 1d agoCRLNegative↗ source
  • Scholar Rock removes Novo Nordisk's Catalent plant from FDA filing for SMA drug apitegromab
    Scholar Rock announced it will no longer list Novo Nordisk’s legacy Catalent facility as a contract manufacturer in its FDA resubmission for apitegromab, its spinal muscular atrophy (SMA) candidate…
    Fierce Biotech · 1d agoRegulatoryNeutral↗ source
  • MoonLake reports all endpoints met in phase 3 trial of sonelokimab for psoriatic arthritis
    MoonLake Immunotherapeutics said its lead nanobody sonelokimab achieved positive topline results in a phase 3 study of patients with psoriatic arthritis. At week 16, 42.1% of participants reached…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • FDA approves Labcorp's BRAF melanoma companion diagnostic
    The FDA has granted approval to Labcorp's companion diagnostic for advanced melanoma patients with specific BRAF mutations. The test, called PGDx elio tissue complete CDx, uses next-generation seq…
    Fierce Biotech · 1d agoApprovalPositive↗ source