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443 stories matching this filter · ← front page

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  • FDA advisory panel set to review Grail’s multi-cancer Galleri screening test
    An FDA advisory committee is scheduled to evaluate Grail’s Galleri blood test, which is designed to detect a range of cancers at an early stage. The panel will examine the test’s clinical data, pe…
    STAT · 12h agoRegulatoryNeutral↗ source
  • Sionna's CF add-on pill fails to improve outcomes in Phase 2 trial with Trikafta
    Sionna Therapeutics reported that its experimental cystic fibrosis pill, SION-719, did not provide any additional benefit when combined with Vertex Pharmaceuticals' Trikafta in a Phase 2 study. Th…
    STAT · 15h agoNegative readoutNegative↗ source
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Vaccines611
Endocrinology & Metabolism318
Ophthalmology313
Pain306
Infectious Disease300
  • 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 · 17h agoDealPositive↗ source
  • FDA rejects ITM-11 radiopharmaceutical over manufacturing flaws, halting rival to Novartis therapy
    The U.S. Food and Drug Administration issued a rejection letter for ITM-11, a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich, citing manufacturing problems that prevent ap…
    STAT · 12h agoRegulatoryNegative↗ source
  • Tenax Therapeutics’ heart-failure drug misses primary goal in Phase 3 trial, shares tumble
    Tenax Therapeutics announced that its experimental oral levosimendan failed to meet the primary efficacy endpoint in the Phase 3 LEVEL study, which evaluated treatment for a form of heart failure l…
    STAT · 15h 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 · 15h agoPositive readoutPositive↗ source
  • Silence Therapeutics’ divesiran shows 88% response in Phase 2 polycythemia vera trial, challenging Takeda’s upcoming drug
    Silence Therapeutics reported results from a Phase 2 study of its RNA-based therapy divesiran in patients with polycythemia vera, a rare blood cancer that causes excessive red blood cell production…
    STAT · 15h 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 · 16h 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 · 17h agoRegulatoryNeutral↗ source
  • Safety concerns emerge as radiopharmaceuticals advance in cancer trials
    Radiopharmaceuticals are being hailed for their ability to deliver radiation directly to tumours, potentially sparing surrounding healthy tissue and improving cancer therapy. However, as more cand…
    STAT · 18h agoNegative↗ 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 · 19h agoApprovalPositive↗ 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 · 16h agoDealPositive↗ source
  • Sobi pens $580M deal for Innate’s skin cancer drug ahead of phase 3 push
    Sobi has bought into Innate Pharma’s vision for lacutamab, handing the French biotech $75 million upfront for the rights to market the anti-KIR3DL2 antibody for an aggressive skin cancer.
    Fierce Biotech · 20h agoDealNeutral↗ source
  • Arpeggio plays final chord as biotech disbands on poor prospects for Nrf2 program
    Arpeggio Biosciences’ eight-year song has come to an end, as the transcriptome biotech’s CEO admitted the that company’s Nrf2 program had begun to “unravel.”
    Fierce Biotech · 22h ago↗ source
  • Silence brings the noise to Takeda with phase 2 blood cancer win
    A phase 2 trial of Silence Therapeutics’ divesiran has hit its primary endpoint, emboldening the biotech to gear up for late-phase development of a potential challenger to Takeda and Protagonist Th…
    Fierce Biotech · 22h ago↗ 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
  • BlossomHill and Latigo Biotherapeutics raise over 30% beyond IPO targets
    Two emerging biotech companies surpassed their initial public offering expectations on Friday, with both BlossomHill Therapeutics and Latigo Biotherapeutics raising at least 30% more capital than p…
    Fierce Biotech · 3d agoDealPositive↗ 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
  • Ensoma cuts staff again to focus on lead gene therapy for rare immune disease
    Boston‑based biotech Ensoma announced another round of layoffs as it narrows its efforts to its sole clinical candidate, EN‑374, aimed at treating X‑linked chronic granulomatous disease (X‑CGD). E…
    Fierce Biotech · 3d agoLayoffsNegative↗ 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
  • Third gender-affirming clinic settles with DOJ as Senate moves to hold Fauci in contempt
    A third clinic that provides gender-affirming services reached a settlement with the Department of Justice, ending a federal investigation into alleged civil-rights violations. The agreement inclu…
    STAT · 3d agoRegulatoryNeutral↗ source
  • FDA grants accelerated approval to Replimune’s melanoma therapy Tudriqev after two prior rejections
    The Food and Drug Administration has granted accelerated approval to Replimune’s RP1 treatment, which will be marketed under the name Tudriqev, for patients with advanced melanoma. An advisory com…
    STAT · 4d agoApprovalPositive↗ source
  • FDA approves first mRNA seasonal flu vaccine, mFlusiva, a year after funding cuts
    The U.S. Food and Drug Administration granted approval to mFlusiva, the first mRNA‑based seasonal influenza vaccine, after its advisory committee voted unanimously that the benefits outweigh the ri…
    STAT · 4d agoApprovalPositive↗ source
  • BioNTech appoints former Sobi chief Guido Oelkers as new CEO
    BioNTech has filled its long-vacant chief executive position after a six-month search. The board selected Guido Oelkers, Ph.D., who most recently led Swedish pharmaceutical company Sobi. At Sobi,…
    Fierce Biotech · 4d agoNeutral↗ source
  • FDA approves Moderna flu vaccine
    The U.S. Food and Drug Administration granted approval to Moderna's seasonal flu vaccine, adding another product to the company's portfolio. The approval was announced late Wednesday, after a repo…
    Endpoints · 5d agoApprovalPositive↗ source