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  • Satellos Bioscience presents early adult data for Duchenne muscular dystrophy pill ahead of child trial
    Satellos Bioscience, a Canadian biotech, has released early results from its Phase 2 study of an oral therapy for Duchenne muscular dystrophy in adult patients. The data are intended to strengthen…
    Endpoints · 1mo agoNeutral↗ source
  • HHS pushes FDA to formalize public release of rejection letters to drug makers
    HHS announced it is preparing a new FDA regulation that would codify the agency's practice of publishing complete response letters (CRLs) that inform pharmaceutical companies of a drug's rejection.…
    Endpoints · 1mo agoCRLNeutral↗ source
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Psychiatry & CNS727
Ophthalmology425
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Infectious Disease362
  • Biohaven targets muscle-sparing obesity market to compete with Lilly's GLP-1 drugs
    Biohaven is positioning itself to address obesity by developing treatments that preserve lean muscle, a differentiator from existing GLP-1 therapies. The company sees an opportunity to act as a "s…
    Endpoints · 1mo agoNeutral↗ source
  • Sanofi proposes to cease negative statements about CSL's flu vaccine amid EU probe
    Sanofi has offered to stop making disparaging comments about CSL's flu vaccine following an investigation launched by the European Commission. The offer comes two weeks after the Commission began p…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Vertex to acquire endocrinology startup Crinetics for $10 billion, signaling push into new therapeutic areas
    Vertex Pharmaceuticals announced a $10 billion cash purchase of Crinetics, an endocrinology-focused biotech. The deal represents the largest acquisition in Vertex’s history and underscores its pla…
    Endpoints · 1mo agoDealPositive↗ source
  • Vera Therapeutics receives accelerated approval for Trutakna to treat IgA nephropathy
    Vera Therapeutics announced that its fusion protein atacicept, branded as Trutakna, has been granted accelerated approval by the FDA for the treatment of immunoglobulin A nephropathy, a chronic aut…
    Endpoints · 1mo agoApprovalPositive↗ source
  • CMS launches ACCESS program to reward Medicare digital health solutions that improve outcomes
    The Centers for Medicare & Medicaid Services introduced the ACCESS program, a new initiative that invites digital health companies to participate in Medicare. The program ties Medicare payments to…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Hengrui and Kailera's oral GLP-1 pill shows promising efficacy but notable side effects in Chinese obesity and diabetes trials
    Hengrui Pharma and Kailera Therapeutics reported results from two late‑stage trials in China, one targeting obesity and the other diabetes, using their daily oral GLP‑1 pill. The studies demonstrat…
    Endpoints · 1mo agoPositive readoutNeutral↗ source
  • Novartis, Vertex and Ipsen announce new acquisitions as M&A activity surges in early July 2026
    Biopharma’s merger and acquisition engine remains robust, with four companies revealing new deals within the first six days of July. The announcements add to a total of 45 acquisitions reported in…
    Endpoints · 1mo agoDealPositive↗ source
  • MeiraGTx secures $135 million royalty deal with Oberland Capital
    MeiraGTx announced a royalty financing agreement with Oberland Capital. The deal provides the gene-therapy company with an initial $135 million, including a $10 million equity investment from Oberl…
    Endpoints · 1mo agoDealPositive↗ source
  • Fresenius Kabi issues correction for Ivenix infusion pumps over battery health software bug
    The U.S. Food and Drug Administration has classified a correction for Fresenius Kabi’s Ivenix Large Volume infusion pump as the most serious type of recall. The action does not require removal of t…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Tampa General Hospital sues Eli Lilly over 340B discount halt
    Tampa General Hospital filed a lawsuit against Eli Lilly, alleging the drugmaker stopped providing 340B program discounts to the hospital. The dispute centers on Lilly's new requirement that hospi…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Compass Pathways reports six-month durability of response in pivotal psilocybin depression trial
    Compass Pathways announced that patients in the second of its two pivotal psilocybin trials for depression continued to show a therapeutic response for at least six months. The durability data sugg…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Fresenius Kabi urges removal of dropped Ivenix infusion pumps after safety correction
    Fresenius Kabi has issued a safety notice for its Ivenix large-volume infusion pumps. The FDA classified the issue as a Class I recall, the most serious level, because the touchscreen can become un…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Digital health firms eye CMS ACCESS Medicare pilot despite modest reimbursement
    A new Medicare initiative called CMS ACCESS is being launched to manage chronic diseases among seniors. The program will contract digital health companies to provide remote monitoring and other se…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Cyllene Therapeutics raises €33 million to pursue HSV-based gene therapy after Krystal model
    Cyllene Therapeutics, a French-US biotech, announced it has secured €33 million in financing. The capital will be used to develop HSV-based gene therapy programs, aiming to replicate the approach…
    Endpoints · 1mo agoDealPositive↗ source
  • Vertex to acquire Crinetics in $10 billion deal to expand endocrinology portfolio
    Vertex Pharmaceuticals announced it will acquire Crinetics Pharmaceuticals for $10 billion, the largest purchase in the company's history. The transaction is aimed at broadening Vertex's commercia…
    Endpoints · 1mo agoDealPositive↗ source
  • AbbVie completes $10.9 billion acquisition of Apogee Therapeutics as UK launches drug pricing pilot
    AbbVie, the Chicago-based pharmaceutical company, finalized its purchase of Apogee Therapeutics for $10.9 billion last month, ending a multi-year negotiation process. The transaction brings Apogee…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA approves 23 new drugs in first half, marking best pace in three years despite staff cuts
    The FDA announced that it has approved 23 novel drugs during the first half of 2026, the strongest approval count in three years. The approvals come after the Trump administration reduced FDA staf…
    Endpoints · 1mo agoApprovalPositive↗ source
  • CMS proposes rule to slash Medicare 340B drug payments by over a third
    CMS announced a proposed rule that would reduce the rates Medicare uses to reimburse hospitals for drugs purchased through the 340B program. The reduction would be more than one-third, effectively…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Novartis to spend $1.1 billion upfront acquiring Myricx Bio and its next-gen ADC platform
    Novartis announced Monday it will invest $1.1 billion in an upfront payment to acquire Myricx Bio. Myricx Bio brings an antibody-drug conjugate (ADC) payload platform that the Swiss group believes…
    Endpoints · 1mo agoDealPositive↗ source
  • Bristol Myers reports Krazati confirmatory trial fails in colorectal cancer
    Bristol Myers Squibb disclosed that the confirmatory study of its investigational drug Krazati in combination with an EGFR inhibitor did not achieve its primary efficacy endpoints in patients with…
    Endpoints · 1mo agoCRLNegative↗ source
  • Roche partners with Otsuka's Astex in $25 million deal to strengthen breast cancer pipeline
    Roche's Genentech subsidiary has signed a collaboration with Astex Pharmaceuticals, a unit of Otsuka, that includes a $25 million upfront payment. The partnership is an early‑stage effort aimed at…
    Endpoints · 1mo agoDealPositive↗ source
  • Windstone Medical issues correction for non-sterile alcohol prep pads in custom convenience kits
    Windstone Medical Packaging, Inc. has released a correction notice for several custom convenience kits that include Cardinal Health Webcol large alcohol prep pads that were found to be non-sterile.…
    fda medwatch · 1mo agoCRLNegative↗ source
  • FDA CDER appoints veteran GLP-1 reviewer Lisa Yanoff as acting deputy director
    Acting FDA CDER director Michael Davis promoted Lisa Yanoff to the role of acting deputy director of the Center for Drug Evaluation and Research. Yanoff is a long‑time FDA employee with deep exper…
    Endpoints · 1mo agoRegulatoryNeutral↗ source