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493 stories matching this filter · ← front page

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  • U.S. Health Secretary Robert F. Kennedy Jr. Advocates Deprescribing of Psychiatric Medications
    U.S. Health and Human Services Secretary Robert F. Kennedy Jr. is intensifying his campaign to encourage Americans to stop using psychiatric drugs, a strategy known as deprescribing. The effort, r…
    STAT · 1mo agoNeutral↗ source
  • Last U.S. polio patient who used an iron lung dies at 78
    Martha Lillard, diagnosed with polio at age five, became the last American still dependent on an iron lung. She lived in Oklahoma, attended grade school two hours a day and completed high school u…
    STAT · 1mo agoNeutral↗ source
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fda recalls67
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fda press38
Ophthalmology492
Pain470
Endocrinology & Metabolism466
Infectious Disease439
Researchers Highlight Tau and Blood‑Brain Barrier Advances at Alzheimer’s Conference
STAT’s AAIC in 30 newsletter reported that tau protein remains the central focus of Alzheimer’s research presented at the recent conference in London. Scientists discussed new strategies aimed at d…
STAT · 1mo agoNeutral↗ source
  • Medical Action Industries issues recall of convenience kits due to risk of particulate contamination
    The FDA’s Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with a Medical Action Industries convenience kit. The alert says that particulates coul…
    fda medwatch · 2mo agoCRLNegative↗ source
  • Lung transplants boost survival for select stage 4 lung cancer patients, study finds
    Northwestern Medicine surgeons and oncologists performed double lung transplants on a small group of stage 4 lung cancer patients whose disease was confined to the lungs. The JAMA study compared 1…
    STAT · 2mo agoPositive readoutPositive↗ source
  • FDA targets online ketamine sellers as health premiums surge, and children 2+ can now obtain CGMs without prescription
    The Food and Drug Administration is intensifying its enforcement against online retailers that sell ketamine, a controlled substance, citing concerns about unregulated distribution and public safet…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • FDA clears first over-the-counter glucose monitor for children 2 and older
    The FDA cleared Dexcom's Stelo continuous glucose monitor for over-the-counter sale, allowing children age 2 and up to obtain the device without a prescription. The agency says real-time glucose d…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Longevity entrepreneur Bryan Johnson reveals he has autoimmune gastritis, a hard-to-diagnose stomach disease
    Bryan Johnson, known for his longevity ventures, announced on X that he has been diagnosed with autoimmune gastritis. The condition is a chronic inflammatory disease where antibodies attack stomac…
    STAT · 2mo agoNeutral↗ source
  • Kailera's oral GLP-1 pill shows ~10% weight loss in Chinese Phase 3 trial
    Kailera Therapeutics reported that its oral GLP-1 candidate HRS-7535 achieved about 10% average weight loss over 44 weeks in a Phase 3 study in China. The highest daily dose led to a mean 9.8% red…
    BioPharma Dive · 2mo agoPositive readoutNeutral↗ 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 · 2mo agoPositive readoutNeutral↗ 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 · 2mo agoCRLNegative↗ 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 · 2mo agoCRLNegative↗ 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 · 2mo agoCRLNegative↗ source
  • Physicians overuse diagnostic tests, urging structural changes to curb waste and antibiotic resistance
    American medicine orders more than 14 billion diagnostic tests each year, but many are performed at the wrong time or on patients who will not benefit. The author argues that while the industry ha…
    STAT · 2mo agoNegative↗ 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 · 2mo agoApprovalPositive↗ 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 · 2mo 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 · 2mo agoRegulatoryNegative↗ source
  • Genetix, formerly Bluebird Bio, claims rapid turnaround and aims to treat 1,000 sickle-cell patients annually by 2030
    David Meek completed a distressed buyout of Bluebird Bio last year and has rebranded the company as Genetix. He says the transaction rescued the firm from the brink of bankruptcy and set it on a pa…
    STAT · 2mo agoDealPositive↗ 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 · 2mo agoApprovalPositive↗ source
  • FDA approves Orca Bio's T-cell therapy to lower graft-versus-host disease risk in blood cancer transplants
    The FDA gave its nod to Orca Bio's personalized T-cell therapy, Tregzi, aimed at patients with blood cancers undergoing stem cell transplants. The therapy is designed to cut the chance of chronic…
    STAT · 2mo agoApprovalPositive↗ source
  • Study finds statins and blood-pressure meds bring middle-aged obese adults' heart risk markers in line with normal-weight peers
    A new 25-year observational study published in The Lancet shows that adults over 40 with obesity have blood‑pressure and cholesterol levels comparable to those of normal‑weight individuals. Resear…
    STAT · 2mo agoPositive readoutPositive↗ 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 · 2mo 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 · 2mo 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 · 2mo agoDealNeutral↗ source
  • Biotech Scorecard Q3 Highlights Upcoming Trial Readouts from Amylyx and Biogen
    STAT’s quarterly biotech scorecard lists fifteen events that could move biotech stocks, focusing on trial readouts and other milestones. Amylyx Pharmaceuticals reported results from its Phase 3 LU…
    STAT · 2mo agoNeutral↗ source