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  • Chile's Frutas y Hortalizas del Sur recalls frozen organic blueberries over possible E. coli O145 contamination
    Frutas y Hortalizas del Sur S.A., based in San Carlos, Chile, announced a recall of its frozen GreenWise Organic IQF Blueberries (10‑oz) because the product may be contaminated with Escherichia col…
    fda recalls · 3mo agoCRLNegative↗ source
  • Cadence raises $100M Series C to advance clinical AI for autonomous medical care
    Cadence, a health tech startup, announced a $100 million Series C financing round aimed at expanding its artificial intelligence platform. The new capital will support development of AI tools that…
    Endpoints · 4mo agoDealPositive
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globenewswire health73
fda press56
Ophthalmology906
Endocrinology & Metabolism729
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Nephrology698
↗ source
  • Mars Petcare voluntarily recalls two lots of Pedigree high-protein wet dog food over possible metal and plastic contamination
    Mars Petcare US announced a voluntary recall of two lots of Pedigree Can High Protein Chopped Chicken & Duck Flavor wet dog food (13.2 oz) after discovering potential foreign material. The recall…
    fda recalls · 4mo agoCRLNegative↗ source
  • Roche’s divarasib shows survival benefit over Amgen and BMS drugs in KRAS G12C lung cancer trial
    Roche reported that its experimental KRAS G12C inhibitor divarasib extended overall survival and progression‑free survival in a Phase 3 head‑to‑head study against Amgen’s Lumakra and Bristol Myers…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • 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 · 4mo 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 · 4mo agoPositive readoutPositive↗ source
  • 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 · 4mo agoDealPositive↗ source
  • FDA grants first clearance for patient-facing LLM diabetes app, marking historic step for AI in medical software
    UpDoc's diabetes management app received FDA clearance, the first for software that uses patient-facing large language models. The app is designed to help patients follow treatment plans set by th…
    STAT · 4mo agoRegulatoryPositive↗ 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 · 4mo agoDealPositive↗ source
  • Roche announces drug that sets new benchmark for KRAS‑driven lung cancer
    Roche has announced a new therapy that it says establishes a new standard of care for patients with KRAS‑driven lung cancer. The announcement was featured in a STAT+ newsletter, underscoring the p…
    STAT · 4mo agoPositive readoutPositive↗ source
  • Biotech Index Surges 30% Year-to-Date as Market Rally Accelerates
    Mid-year data show the biotech sector continuing a strong rally that began in April 2025. The XBI index, the most-watched biotech gauge, rose 19% in June and is up about 30% for the year, trading…
    STAT · 4mo agoPositive↗ 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 · 4mo agoCRLNegative↗ 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 · 4mo agoDealNeutral↗ source
  • Medicare proposes 33% cut to 340B drug payments for hospitals
    Medicare has released a proposal to cut payments to hospitals for drugs bought through the 340B discount program by more than a third. Under the plan, Medicare would reimburse hospitals at the aver…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Lawmakers ask HHS to compel Eli Lilly to resume 340B hospital discounts
    A bipartisan group of congressional lawmakers has written to HHS Secretary Robert F. Kennedy Jr., urging the department to require Eli Lilly to restore 340B drug discounts for hospitals. Lilly hal…
    STAT · 4mo agoRegulatoryNegative↗ 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo agoCRLNegative↗ source
  • U.S. Judge Blocks Colorado Panel’s Attempt to Cap Amgen’s Enbrel Price
    A federal judge in the United States issued an order that prevents a Colorado state panel from imposing a price cap on Amgen’s blockbuster arthritis drug Enbrel. The ruling effectively blocks the s…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Federal judge halts Colorado price cap on Amgen's Enbrel drug
    A U.S. district judge issued an injunction that stops the Colorado Prescription Drug Affordability Board from imposing a payment limit on Enbrel, a high-volume biologic sold by Amgen. The court fou…
    STAT · 4mo agoRegulatoryPositive↗ 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 · 4mo agoRegulatoryPositive↗ source
  • Former FDA AI regulator says biopharma is misreading agency's guidance, leading to overly cautious approaches
    Tala Fakhouri, who wrote AI policy at the FDA, left the agency last summer and now serves as chief AI and regulatory strategy officer at contract research organization Parexel. She says biopharma…
    STAT · 4mo agoRegulatoryNegative↗ 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 · 4mo agoPositive↗ source