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3,027 stories matching this filter · ← front page

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  • FDA issues warning letter to Bausch & Lomb over aseptic processing concerns
    FDA sent a warning letter to Bausch & Lomb after inspectors reviewed the company’s response to earlier observations at its Florida plant. The agency said the response did not demonstrate a commitme…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Sling Therapeutics raises $123M Series C to advance oral thyroid eye disease drug
    Sling Therapeutics raised $123 million in a Series C financing round to move its oral drug candidate for thyroid eye disease forward. The capital will fund development of linsitinib, the only late…
    BioSpace · 1mo agoDealPositive↗ source
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  • U.S. sees highest number of measles deaths in decades as outbreak spreads to 693 cases
    The United States has recorded four measles-related deaths so far in 2026, the highest number of deaths from the disease in any year since 1992. The deaths occurred in Pennsylvania, where the outb…
    STAT · 1mo agoNeutral↗ source
  • Dementia should be a campaign issue, not a political insult, says expert
    Jason Karlawish, a professor at Penn and co‑director of the Penn Memory Center, argues that dementia deserves serious policy focus during the upcoming election. He notes that about 7.1 million Ame…
    STAT · 1mo agoNeutral↗ source
  • Biotech firms race to hire AI-savvy scientists as talent gap widens
    AI is becoming integral to biotech research and development, prompting companies to seek staff who can blend biology with machine learning and data engineering. Recruiters say the hardest-to-find…
    BioSpace · 1mo agoNeutral↗ source
  • Biotech firms increase product launches as capital markets improve
    A growing number of biotech companies are bringing new medicines to market, a trend analysts link to improving capital markets. While the majority of approved drugs still come from large pharmaceu…
    BioSpace · 1mo agoPositive↗ source
  • Experts urge more representative enrollment in clinical trials
    A panel of regulators and industry leaders gathered to discuss how clinical trials can better reflect the diversity of patient populations. The discussion included officials from the U.S. Food and…
    raps · 1mo agoRegulatoryNeutral↗ source
  • GOP Bill Seeks to Tilt Medicare Advantage Study Toward Insurers
    Republicans on the House Ways and Means Committee advanced a bill that would direct the Medicare Payment Advisory Commission, MedPAC, to study Medicare Advantage spending in a way that favors insur…
    STAT · 1mo agoRegulatoryNegative↗ source
  • WHO sees declining Ebola transmission in DRC but warns months of work remain
    The World Health Organization’s director‑general said on Wednesday that transmission rates of Ebola are falling in most provinces of the Democratic Republic of the Congo, offering a reason for caut…
    STAT · 1mo agoPositive↗ source
  • Novartis stops ALS TREM2 stabilizer after Phase 2 miss, marking fourth trial setback in a month
    Novartis has halted development of its TREM2 stabilizer VHB937, also known as lifonebart, for amyotrophic lateral sclerosis after the drug failed to meet either the primary or secondary endpoints i…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Sen. Warren calls for release of Trump-era pharma pricing contracts amid accusations against RFK Jr.
    Sen. Warren has publicly demanded that the contracts governing drug pricing under the Trump administration be disclosed. She alleges that RFK Jr. is concealing these agreements, raising concerns ab…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • FDA opens applications for pilot program to speed up first-in-human testing
    The U.S. Food and Drug Administration announced that it is now accepting applications for a pilot program designed to shorten the time required for drug developers to begin first‑in‑human clinical…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Senators probe nominee Chris Klomp’s influence on HHS health-policy and drug pricing
    Senators on the Finance and Energy committees held two days of hearings to examine the authority that Chris Klomp would have if confirmed as deputy secretary of HHS. Klomp, a senior adviser who se…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Democrats pledge to use oversight powers to push health-care reforms if they win Congress
    House Democrats say they will employ congressional oversight to advance a health-care overhaul should they gain control of the House or Senate. They intend to focus on health-care topics, includin…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Experts assess EU medical device and diagnostic regulations at RAPS Convergence 2026
    A panel of experts representing the European Commission, industry groups and notified bodies gathered in Charlotte, North Carolina during RAPS Convergence 2026. The group reviewed the current stat…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Biopharma workers increasingly postpone retirement, poll shows 52% plan to stay longer
    Biopharma professionals are rethinking retirement, with a BioSpace LinkedIn poll indicating that 52% expect to retire later than originally planned. Overall, 63% of respondents said they have chang…
    BioSpace · 1mo agoNeutral↗ source
  • Professor uses his own thymic cancer journey to teach medical students about real-world oncology
    David Elkowitz, a professor of pathology and laboratory medicine at Hofstra/Northwell, writes about how his personal battle with thymic cancer shapes his teaching. He now brings his own case into…
    STAT · 1mo agoPositive↗ source
  • Saratoga Potato Chips recalls J. HIGGS Loaded Bacon & Cheddar chips over undeclared soy allergen
    Saratoga Potato Chips of Fort Wayne, Indiana announced a recall of two best‑if‑used‑by codes of its 7.75‑ounce J. HIGGS Loaded Bacon and Cheddar potato chips because the product may contain undecla…
    fda recalls · 1mo agoCRLNeutral↗ source
  • Vera Therapeutics' Trutakna shows kidney function stabilization and lower death risk in Phase 3 IgAN trial
    Vera Therapeutics reported that its drug Trutakna met its primary goals in a two‑year Phase 3 study of patients with IgA nephropathy. The therapy stabilized kidney function and lowered the risk of…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Fourth measles death reported in Pennsylvania, all victims unvaccinated
    Pennsylvania health officials reported a fourth measles-associated death in the state, involving an 18-year-old from Mifflin County. The death was caused by acute disseminated encephalomyelitis, a…
    STAT · 1mo agoNegative↗ source
  • GSK to acquire Chimagen’s trispecific T-cell engager program in deal up to $750 million
    GSK announced it will acquire a preclinical trispecific T cell engager program from Chinese biotech Chimagen Biosciences in a transaction that could total up to $750 million. The agreement provide…
    BioSpace · 1mo agoDealPositive↗ source
  • Medicare AI prior-authorization pilot plagued by rollout glitches, causing care delays
    Documents obtained through a Freedom of Information Act lawsuit reveal that the Medicare program using artificial intelligence for prior authorization was launched hastily and suffered numerous tec…
    STAT · 1mo agoRegulatoryNegative↗ source
  • FDA launches Operation TrialBlazer to accelerate early-stage drug trials and bring research back to the U.S.
    The FDA announced it is now accepting applications for Operation TrialBlazer, an expedited IND pilot program. The program pairs drug sponsors with qualified U.S. research institutions to cut the r…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Medicare expands ACCESS pilot to cover more chronic conditions with outcome-based payments
    Medicare's ACCESS model, a pilot that pays technology providers for managing chronic diseases, is being broadened. Initially covering diabetes, hypertension, chronic musculoskeletal pain, depressi…
    STAT · 1mo agoRegulatoryPositive↗ source
  • FDA opens pilot program to speed human testing of new drugs
    The Food and Drug Administration announced it is accepting applications for a pilot under Operation TrialBlazer aimed at reducing the time before drug candidates can start human trials. The initia…
    STAT · 1mo agoRegulatoryPositive↗ source