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  • Australia's TGA opens consultation to revamp rules for digital mental health tools
    The Therapeutic Goods Administration (TGA) has launched a public consultation aimed at updating the regulatory framework that governs digital mental health tools in Australia. The move seeks to cla…
    raps · 26d agoRegulatoryNeutral↗ source
  • Fugitive ex-doctor arrested after two decades posing as biotech executive
    Federal and Rhode Island authorities arrested Ronald Fischer, 70, after tracking a 56-foot sailboat off New Jersey. He had been on the run for about 20 years. Fischer, a former anesthesiologist, v…
    STAT · 26d agoRegulatoryNegative↗ source
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  • U.S. Military's New Testosterone Screening Raises Health Concerns
    The Department of Defense announced a mandatory testosterone screening program for all service members, prompting discussion among medical experts. A urologist who studies men’s health cautions th…
    STAT · 28d agoNegative↗ source
  • STAT invites reader letters on primary care value, obesity as disease and broader health-care debates
    STAT’s First Opinion platform encourages readers to submit letters responding to its essays, fostering open, good‑faith discussion about health‑care topics. Recent letters, echoing comments from t…
    STAT · 28d agoNeutral↗ source
  • Biogen reports mixed Alzheimer’s trial results as industry sees new startup launches
    Biogen released data from its Alzheimer’s program that showed mixed outcomes, indicating some signals but also setbacks. The weekly newsletter also highlighted the launch of two new biotech startu…
    Endpoints · 28d agoNeutral↗ source
  • FDA approves Lipfendra, first oral PCSK9 inhibitor, to lower LDL cholesterol in adults
    The U.S. Food and Drug Administration has approved Lipfendra (enlicitide), the first oral inhibitor of the PCSK9 protein, for use as an adjunct to diet and exercise in adults with high cholesterol,…
    fda press · 29d agoApprovalPositive↗ source
  • BlossomHill and Latigo lead a surge of biotech IPOs after summer dry spell
    After a seven‑month lull that left no biotech companies on the public markets last summer, the sector is seeing renewed activity. BlossomHill Therapeutics and Latigo have filed to list on Nasdaq,…
    Endpoints · 29d agoDealPositive↗ source
  • Sonothera reports ultrasound method delivers high levels of dystrophin in monkeys, a potential new route for Duchenne therapy
    A California startup, Sonothera, is proposing an ultrasound‑based approach to deliver genes for Duchenne muscular dystrophy treatment. The company says its technology can introduce full-size dystr…
    STAT · 29d agoPositive readoutNeutral↗ source
  • Mid-size biotech firms urge White House to scrap CMS GLOBE and GUARD pricing proposals
    A group of midsized biotechnology companies met with officials from the White House and the Department of Health and Human Services this week. The companies presented a coordinated case to senior p…
    Endpoints · 29d agoRegulatoryNegative↗ source
  • Celcuity's Revtorpyk receives FDA approval, but launch delay pushes stock lower
    The FDA announced approval of Celcuity’s oncology candidate Revtorpyk on Tuesday, marking the company’s first cancer drug clearance. Analysts had broadly expected the approval and had priced the s…
    Endpoints · 29d agoApprovalNeutral↗ source
  • Medicare proposal would boost doctor pay for smoking and alcohol counseling by 19%
    A proposed change to Medicare’s physician fee schedule would increase reimbursement for doctors who provide counseling on tobacco cessation and alcohol or substance misuse. The proposal adds a 19%…
    STAT · 29d agoRegulatoryPositive↗ source
  • India’s life-sciences sector faces scaling hurdles despite rapid innovation growth, report says
    India’s life‑sciences sector has shown rapid growth, according to a new report by Boston Consulting Group and HealthKois. Patent filings have risen more than four‑fold since 2016, the pipeline of i…
    BioSpace · 29d agoNeutral↗ source
  • GSK to launch large trial testing shingles vaccine’s potential to reduce Alzheimer’s risk
    GSK announced it will conduct a large-scale clinical study to evaluate whether the shingles vaccine can lower the risk of developing Alzheimer’s disease. The move follows observations from analyses…
    Endpoints · 29d agoNeutral↗ source
  • U.S. drug shortages climb to 227 active cases in Q2 2026
    The United States reported a rise in active medication shortages during the second quarter of 2026, with the total reaching 227. The increase signals growing pressure on the pharmaceutical supply…
    STAT · 29d agoNeutral↗ source
  • GSK drops chronic cough drug camlipixant after mixed Phase 3 results
    GSK announced it will stop investing in camlipixant for refractory chronic cough after the drug failed to meet key endpoints in a late-stage trial. The company had run two Phase 3 studies, CALM-1…
    BioSpace · 29d agoNegative readoutNegative↗ source
  • Insmed's inhaled PAH therapy shows durable efficacy in 12-month extension, bolstering $6B sales outlook
    Insmed reported that its inhalable prostanoid candidate, treprostinil palmitil inhalation powder (TPIP), maintained functional and biomarker benefits through a 12‑month open‑label extension in pati…
    BioSpace · 29d agoPositive readoutPositive↗ source
  • FDA says former officials' journal articles do not represent agency policy after lawmaker criticism
    Acting FDA director Kyle Diamantas wrote to House Energy & Commerce ranking member Diana DeGette, stating that journal papers authored by former agency officials do not convey FDA policy or regulat…
    BioSpace · 29d agoRegulatoryNegative↗ source
  • GSK halts Phase 3 chronic cough drug camlipixant, jeopardizing $2 billion Bellus Health acquisition
    GSK announced it is ending development of camlipixant, a drug aimed at treating refractory chronic cough, after completing Phase 3 trials. The move comes as the company proceeds with its planned $…
    Endpoints · 29d agoNegative↗ source
  • MDCalc introduces quality-rating system for over 800 clinical calculators used by doctors
    MDCalc, a health‑technology company, announced a new quality‑rating system that will evaluate the more than 800 clinical calculators doctors rely on for decisions such as kidney function, birth out…
    STAT · 29d agoPositive↗ source
  • FDA proposal to drop adequate provision could effectively ban prescription drug ads
    FDA staff are proposing to eliminate the adequate provision requirement in direct-to-consumer prescription-drug advertisements. The adequate provision currently obliges advertisers to present a bal…
    raps · 29d agoRegulatoryNegative↗ source
  • Pharma industry backs FDA NGS guidance but seeks clarification on off-target data and manufacturing changes
    The pharmaceutical sector has broadly endorsed the FDA's recent guidance on using next‑generation sequencing to evaluate the safety of human gene‑therapy products. Despite this support, companies…
    raps · 29d agoRegulatoryNeutral↗ source
  • FDA staff flag peptide conflict concerns and warn drug ad rule could curb advertising
    FDA staff have raised internal concerns about potential conflicts of interest among experts who will sit on an upcoming advisory panel reviewing peptide therapies. The staff memo warns that undiscl…
    raps · 29d agoRegulatoryNegative↗ source
  • CDC links Taco Bell lettuce in five states to cyclospora outbreak
    Federal health officials have identified shredded iceberg lettuce from Mexico served at Taco Bell restaurants in Indiana, Kentucky, Michigan, Ohio and West Virginia as the source of a widespread cy…
    STAT · 29d agoRegulatoryNegative↗ source
  • GSK discontinues its chronic cough therapy amid uncertain future
    GSK has announced that it is ending development of its chronic cough treatment. The decision marks the conclusion of the program that had been under investigation for several years. The article do…
    STAT · 29d agoNegative↗ source
  • Dimerix acquires Mission’s acute kidney injury candidate for $5 million upfront
    Dimerix announced it has signed a deal to acquire a kidney injury drug candidate from Mission Therapeutics. The asset is ready to enter Phase 2 trials for the treatment of acute kidney injury. Und…
    Endpoints · 29d agoDealPositive↗ source