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  • 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
  • Abiomed recalls Impella CP Sets with SmartAssist over low purge pressure risk
    Abiomed has issued a recall of specific Impella CP Sets with SmartAssist after discovering that the units do not meet design specifications. The defect can cause low purge pressure events from the…
    fda medwatch · 1mo agoCRLNegative↗ source
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Psychiatry & CNS727
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Infectious Disease364
  • 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
  • Hamilton Medical issues updated use instructions for certain breathing circuit sets after serious recall
    Hamilton Medical has sent a letter to customers on May 18, 2026, advising updated use instructions for specific coaxial breathing circuit sets used with its HAMILTON-C1, HAMILTON T-1 and HAMILTON-M…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Merck scraps a Phase 2 Alzheimer's asset from partner Neuphoria
    Merck has axed a Phase 2 trial testing an experimental Alzheimer’s medicine, Endpoints News has learned. The company terminated a mid-stage test of the oral drug candidate MK-1167, a Merck spokespe…
    Endpoints · 1mo ago↗ source
  • FDA warns Genzyme's Irish site over quality questions
    An FDA warning letter sent late last month to Genzyme's Ireland-based manufacturing site, now owned by Sanofi, raises significant quality- and data-related issues. On data integrity, the warning le…
    Endpoints · 1mo ago↗ source
  • WuXi AppTec seeks injunction over China military list
    WuXi AppTec has filed for a preliminary injunction to suspend its place on the Pentagon’s list of companies with alleged ties to the Chinese military. The injunction, dated June 29, seeks to stop t…
    Endpoints · 1mo ago↗ source
  • FDA approves Orca Bio’s cell therapy to improve transplant outcomes
    The FDA gave the go-ahead to Orca Bio’s T cell therapy that would reduce transplant-related complications for blood cancer patients. The therapy will be branded as Tregzi, an homage to the regulato…
    Endpoints · 1mo ago↗ source
  • BridgeBio gets funding for drug launch; United buys into cell therapy
    Elsewhere, Otsuka’s kidney drug hit the goal of a confirmatory trial and Vertex’s CRISPR sickle cell drug secured expanded approval.
    BioPharma Dive · 1mo ago↗ source
  • BridgeBio adds $1B as it prepares three more drug launches
    BridgeBio Pharma has reloaded with about $1 billion in a preferred equity deal to bolster its reserves ahead of three potential drug launches over the next year. The California biotech, which for y…
    Endpoints · 1mo ago↗ source
  • Ipsen to buy Swiss biotech Memo Therapeutics in potential $800M deal
    The purchase hands Ipsen an experimental medicine in late-stage testing for a virus that often affects kidney transplant patients.
    BioPharma Dive · 1mo ago↗ source
  • 92Bio revives a T cell engager it had transferred to Amgen
    A small California startup is reviving an experimental T cell engager that its scientists originally developed but had handed off to Amgen years ago. After repeatedly saying it would bring the drug…
    Endpoints · 1mo ago↗ source
  • Angitia ends Phase 3 in disc disease; Abivax targets $800M on colitis data
    🩻 Angitia Biopharmaceuticals drops Phase 3: The US and China biotech terminated a late-stage trial of AGA111 in patients with degenerative disc disease who had a lumbar interbody fusion, according…
    Endpoints · 1mo ago↗ 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
  • Abivax shares surge as worries subside over immune drug’s cancer risk
    According to Abivax, fresh data suggest malignancy rates in its trials were no higher than "background" ones for people with ulcerative colitis, clearing a key safety concern.
    BioPharma Dive · 1mo ago↗ source
  • Ipsen to scoop up Memo Therapeutics and its kidney infection drug
    Ipsen is on an M&A roll. The French drugmaker announced its second deal of the week, saying it would buy Memo Therapeutics and its drug candidate called potravitug for a viral ...
    Endpoints · 1mo ago↗ source