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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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Infectious Disease364
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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
  • 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
  • Gellert Global Group recalls ALDI Fusia Kimchi & Tofu Kimbap over undeclared tuna
    Gellert Global Group of Elizabeth, NJ announced a recall of 8.1-oz packages of ALDI's Fusia Asian Inspirations Kimchi & Tofu Kimbap because they may contain undeclared tuna. The undeclared fish po…
    fda recalls · 1mo agoCRLNegative↗ 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
  • 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
  • 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
  • Kao USA issues voluntary recall of select Oribe scalp shampoo lots over bacterial contamination
    Kao USA announced a voluntary recall of select lots of its Oribe Serene Scalp Densifying Shampoo in the United States and Canada after detecting the bacterium Pluralibacter gergoviae. The recall a…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Eunha Fisheries recalls frozen halibut and flounder sashimi after undisclosed wheat, soy, sesame found in condiment packets
    On July 1, 2026, Eunha Fisheries Co., Ltd. of Busan, South Korea announced a recall of certain sliced Korean halibut and flounder sashimi products. The recall covers items that were sold in the Uni…
    fda recalls · 1mo agoRegulatoryNegative↗ 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
  • 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
  • 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