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  • Vertex's Casgevy gene therapy receives FDA approval for children with sickle cell disease and beta-thalassemia
    Vertex announced that its gene therapy Casgevy has been granted FDA approval for use in pediatric patients. The decision expands the therapy's reach beyond adult indications. Casgevy is now author…
    Endpoints · 1mo agoApprovalPositive↗ source
  • Roche's KRAS G12C inhibitor divarasib outperforms Amgen and Bristol Myers Squibb drugs in Phase 3 head-to-head trial
    Roche announced that its KRAS G12C inhibitor divarasib showed superiority over existing marketed therapies from Amgen and Bristol Myers Squibb in a Phase 3 head-to-head trial in lung cancer. The t…
    Endpoints · 1mo agoPositive readoutPositive
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  • AstraZeneca signs up to $1.7 billion R&D pact with China’s CSPC, marking second deal in six months
    AstraZeneca announced a new research collaboration with Chinese partner CSPC, valued at up to $1.7 billion. The agreement follows a previous large biobucks deal signed less than six months earlier…
    Endpoints · 1mo agoDealPositive↗ source
  • Celea Therapeutics raises $180 million to advance next-generation IPF drug deupirfenidone
    Celea Therapeutics, a PureTech Health spinout, announced a $180 million venture round to fund development of its next-generation idiopathic pulmonary fibrosis (IPF) therapy, deupirfenidone. The ro…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Scribe Therapeutics files for Nasdaq IPO, testing market appetite for early-stage gene-editing firms
    Scribe Therapeutics announced it has filed a registration statement to list its shares on the Nasdaq, marking the company’s first step toward a public offering. The filing highlights the growing i…
    Endpoints · 1mo agoDealNeutral↗ source
  • Colorado judge blocks 70% price cap on Amgen's Enbrel, citing potential economic injury
    A U.S. District Court in Colorado issued a preliminary injunction that stops a state‑imposed 70% price cap on Amgen's autoimmune drug Enbrel. The ruling was made by Judge Daniel Domenico, who grant…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Revolution Medicines reports promising early data for KRAS drug combo, plans Phase 3 in pancreatic cancer
    Revolution Medicines presented early-stage results that support moving forward with a Phase 3 study of a combination of two KRAS-targeted agents in pancreatic cancer. The data, shown for the first…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Otsuka presents long-term Phase 3 data for Voyxact, aiming to secure full FDA approval for kidney disease
    Otsuka announced new long-term results from the Phase 3 trial of its kidney disease drug Voyxact. The data show that the therapy stabilized kidney function over an extended period, building on ear…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Celea Therapeutics secures $180M financing to advance IPF pipeline
    Celea Therapeutics, an idiopathic pulmonary fibrosis (IPF) biotech, announced it has raised $180 million from a group of new investors. The funding is intended to help the company follow the devel…
    Endpoints · 1mo agoDealNeutral↗ source
  • Galderma receives FDA complete response letter for anti-wrinkle neuromodulator
    Galderma has been issued a complete response letter by the U.S. Food and Drug Administration for its experimental anti-wrinkle product relabotulinumtoxinA, which was under review as a neuromodulato…
    Endpoints · 1mo agoCRLNegative↗ source
  • BrightGene advances obesity drug toward Chinese approval, eyes Western data and partners
    BrightGene has submitted its obesity GLP-1 candidate to Chinese regulators after reporting strong Phase 3 results. The company says data from Western trials are expected to be even more robust, wh…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Sandoz launches direct-to-consumer platform with growth-hormone biosimilar Omnitrope
    Sandoz announced a direct-to-consumer platform, initially offering Omnitrope, a biosimilar growth hormone for growth disorders. The approach follows a trend among brand-name manufacturers to lower…
    Endpoints · 1mo agoPositive↗ source
  • Butterfly expands from handheld ultrasound to chip manufacturing
    Butterfly, known for its portable ultrasound device, is shifting focus toward building its own semiconductor business. The move mirrors Nvidia's evolution from a gaming‑chip maker to a supplier fo…
    Endpoints · 1mo agoPositive↗ source
  • Michel Detheux appointed CEO of Muna Therapeutics, GSK Alzheimer’s partner, as Genentech loses scientist Alex Hoffman
    Michel Detheux has taken over as chief executive of Danish neuro‑biotech Muna Therapeutics, succeeding Rita Balice‑Gordon in the role. Muna Therapeutics continues its collaboration with GlaxoSmith…
    Endpoints · 1mo agoNeutral↗ source
  • FDA Grants First Gene-Therapy Approval for Children 2+ with Sickle Cell Disease
    The U.S. Food and Drug Administration issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged two years and older who have sickle cell disease with recurrent vaso-oc…
    fda press · 1mo agoApprovalPositive↗ source
  • FDA issues warning letter to Sanofi's Genzyme Irish manufacturing site over quality and data integrity concerns
    The U.S. Food and Drug Administration sent a warning letter late last month to the Ireland‑based manufacturing facility operated by Genzyme, which is now owned by Sanofi. The agency highlighted se…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Ipsen to acquire Swiss biotech Memo Therapeutics in up to €800 million deal for BK virus drug
    Ipsen announced it will purchase Memo Therapeutics, a Swiss biotech, in a transaction valued at up to about €800 million. The agreement provides Memo investors with €200 million upfront and potent…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • FDA approves Orca Bio's T cell therapy Tregzi to lower transplant complications in blood cancer patients
    The U.S. Food and Drug Administration has granted approval to Orca Bio's T cell therapy aimed at improving outcomes for patients undergoing blood cancer transplants. The therapy, named Tregzi, is…
    Endpoints · 1mo agoApprovalPositive↗ source
  • BridgeBio secures up to $1 billion in preferred equity as United Therapeutics invests $140 million to acquire Thymmune
    BridgeBio Pharma announced that Sixth Street Partners and HealthCare Royalty will provide up to $1 billion in preferred equity to support its upcoming product launches. The financing is structured…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • BridgeBio secures $1 billion in equity financing ahead of three upcoming drug launches
    BridgeBio Pharma announced it has raised about $1 billion through a preferred equity transaction. The new capital will strengthen its balance sheet as the company prepares three potential drug lau…
    Endpoints · 1mo agoDealNeutral↗ source
  • Angitia halts Phase 3 trial of AGA111 for degenerative disc disease
    Angitia Biopharmaceuticals announced that it has ended the Phase 3 study of its investigational therapy AGA111 in patients with degenerative disc disease who had undergone lumbar interbody fusion.…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Merck ends Phase 2 trial of Alzheimer’s drug MK-1167 from partner Neuphoria
    Merck announced it has terminated a mid-stage Phase 2 study of an experimental Alzheimer’s therapy. The drug, called MK-1167, is an oral candidate that was being developed in collaboration with bi…
    Endpoints · 1mo agoNegative↗ source
  • WuXi AppTec seeks court order to remove itself from U.S. Pentagon's Chinese military-linked company list
    WuXi AppTec has filed a petition for a preliminary injunction to halt its inclusion on the Pentagon's list of firms with alleged ties to the Chinese military. The company says the designation is d…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • 92Bio revives experimental T cell engager previously handed to Amgen
    92Bio, a small California biotech, announced it is bringing back an experimental T‑cell engager it originally created before transferring the program to Amgen. The company said the candidate will…
    Endpoints · 1mo agoNeutral↗ source
  • 5 FDA decisions to watch in the third quarter of 2026
    A group of coming decisions could provide important insights into how flexible the agency is willing to be under new leadership.
    BioPharma Dive · 1mo ago↗ source