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3,621 stories matching this filter · ← front page

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  • Nobel prize honors scientists who pioneered light-activated gene therapy technology
    Three researchers received this year’s Nobel Prize in medicine for creating optogenetics, a technique that uses light to steer nerve activity. The award recognizes their foundational work that has…
    Endpoints · 16d agoPositive↗ source
  • Sensible Bio raises $47 million Series A to build mRNA therapy manufacturing platform
    Sensible Biotechnologies announced it has closed a $47 million Series A financing round. The capital will be used to develop its proprietary manufacturing platform for mRNA based therapies. The fu…
    Endpoints · 16d agoDealPositive↗ source
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  • Epicrispr reports encouraging early data from EPI-321 in 12 patients with FSHD
    Epicrispr Biotechnologies released updated data on its epigenetic editing therapy EPI-321 aimed at treating facioscapulohumeral muscular dystrophy (FSHD). The company has now dosed twelve particip…
    Endpoints · 16d agoPositive readoutPositive↗ source
  • 2026 Nobel Prize in Medicine awarded for optogenetics, the light-controlled brain research tool
    Karl Deisseroth, Peter Hegemann and Georg Nagel were named the 2026 Nobel laureates in Physiology or Medicine for their work on light-gated ion channels and the optogenetics technique. The Karolins…
    STAT · 16d agoPositive↗ source
  • Rising Hospital and Drug Prices Drive Up Insurance Premiums for Workers and Employers
    Bob Herman’s investigation, based on interviews with more than twenty health policy experts and industry leaders, finds that soaring hospital and pharmaceutical prices are the primary force behind…
    STAT · 16d agoNegative↗ source
  • Kyverna Therapeutics reports encouraging data for first CAR-T therapy targeting autoimmune disease
    Kyverna Therapeutics released new data that strengthens its case for bringing the first CAR‑T treatment for an autoimmune condition to market. The results come after recent safety setbacks in simil…
    BioSpace · 16d agoPositive readoutNeutral↗ source
  • Roivant Sciences launches first solo drug, Lisraya, after FDA approval for dermatomyositis
    Roivant Sciences, which operates a hub-and-spoke subsidiary model, is stepping into the commercial arena with its inaugural solo product launch. The FDA has granted approval to the oral TYK2/JAK i…
    BioSpace · 16d agoApprovalPositive↗ source
  • CSL agrees $355M upfront deal to co-develop Alentis anti-fibrosis drug for kidney and liver
    CSL, an Australian drugmaker, announced a partnership with Alentis Therapeutics that includes a $355 million upfront payment. Under the agreement, CSL will co-develop Alentis's anti-fibrosis candi…
    Endpoints · 16d agoDealNeutral↗ source
  • FDA delays review of Novo's hemophilia A drug denecimig over factory issues
    US regulators have extended the review of Novo's hemophilia A injection, denecimig, because of problems at an unnamed manufacturing facility. The FDA said ongoing remediation activities observed d…
    Endpoints · 16d agoRegulatoryNegative↗ source
  • CSL strikes up to $1.6B deal with Alentis for autoimmune drug with broad potential
    CSL will co-develop and co-promote Alentis Therapeutics' anti-claudin-1 therapy lixudebart for kidney and liver conditions, including primary sclerosing cholangitis and a systemic autoimmune diseas…
    BioSpace · 16d agoDealNeutral↗ source
  • 2026 Nobel Prize awarded to U.S. and German scientists for optogenetics breakthroughs
    The 2026 Nobel Prize in Physiology or Medicine was awarded to three researchers for their pioneering work on optogenetics. The laureates-Karl Deisseroth of Stanford University and the Howard Hughe…
    STAT · 16d agoNeutral↗ source
  • Stem cell advocates anticipate FDA roundtables as peptide therapies gain regulatory foothold
    At PepMed 2026, a conference focused on peptide medicines, stem cell entrepreneur Chuck Meeker said he expects the FDA to hold a series of roundtables on regenerative therapies before year‑end. He…
    STAT · 16d agoRegulatoryNeutral↗ source
  • Swiss CDMOs and CROs experience rapid growth as global sponsors seek specialized manufacturing and decentralized trials
    Switzerland’s contract development and manufacturing organisations (CDMOs) and contract research organisations (CROs) are entering a new boom cycle, driven by rising global demand for specialised m…
    BioSpace · 16d agoDealPositive↗ source
  • FDA warns Evolus over misleading Instagram claims about Jeuveau
    The FDA's Office of Prescription Drug Promotion sent an untitled warning letter to Evolus, the maker of the injectable cosmetic product Jeuveau. The letter says the company exaggerated the drug’s…
    raps · 16d agoRegulatoryNegative↗ source
  • Bayer to invest $2.2B in new Ohio manufacturing complex as FDA CDER opens clinical trial modernization office
    Bayer announced plans to spend roughly $2.2 billion on a new manufacturing site in Ohio, aiming to broaden its production capabilities. The investment is projected to increase capacity and generat…
    raps · 16d agoRegulatoryNeutral↗ source
  • Staggering health insurance premiums force employers to rethink coverage options
    Employers are confronting staggeringly high health insurance premiums, according to a STAT+ newsletter by reporter Bob Herman. The piece highlights how rising costs are forcing some businesses to r…
    STAT · 16d agoNegative↗ source
  • Will AI like Claude ever earn a Nobel Prize in medicine?
    Jeffrey S. Flier, a distinguished professor at Harvard and former dean of Harvard Medical School, writes an opinion piece prompted by the recent Nobel announcement. He asks whether an artificial-in…
    STAT · 16d agoNeutral↗ source
  • FDA Requests Public Feedback on Designing Early-Phase Trials for Psychedelic Drug Ibogaine
    The U.S. Food and Drug Administration announced it is seeking comments from the public on how to structure early-phase clinical studies of ibogaine, a plant-derived psychoactive compound. The agen…
    raps · 16d agoRegulatoryNeutral↗ source
  • Federal Appeals Judges Reject HHS Arguments in Humana Medicare Advantage Audit Lawsuit
    Federal appeals judges on Monday rebuked the Health and Human Services Department's arguments in a hearing on Humana's lawsuit challenging a new Medicare Advantage audit rule. Humana, the nation's…
    STAT · 16d agoRegulatoryNeutral↗ source
  • Genentech parts ways with global AI head Richard Bonneau
    Genentech, the Roche biotech unit, announced that its global head of artificial intelligence for drug discovery, computational biologist Richard Bonneau, has left the company effective immediately.…
    Endpoints · 16d agoNegative↗ source
  • Australia's TGA begins five-year transition to new medicine labeling standards
    The Therapeutic Goods Administration has adopted two new labeling standards for medicines in Australia. The standards will become mandatory after a five-year transition period that starts now. Ph…
    raps · 16d agoRegulatoryNeutral↗ source
  • Two Massachusetts biotech firms shut down, ending cancer and eye‑disease programs
    Adecto Pharmaceuticals, a Boston‑based biotech developing a treatment for cancers resistant to standard immunotherapy, announced it has ceased operations as of September 30. CEO Nora Minerva shared…
    BioSpace · 16d agoNegative↗ source
  • Report highlights 20 women reshaping biopharma across oncology and rare disease fields
    The 2026 special report spotlights twenty women who are driving change in biopharma, covering areas such as oncology and rare diseases. The series, now in its eighth year, has recognized over 160…
    Endpoints · 16d agoPositive↗ source
  • Energy drinks partner with college sports, raising safety concerns for teens
    Kent Sepkowitz, a professor emeritus at Weill‑Cornell Medical College, writes that energy drinks have grown into an $85‑billion global market and are now being marketed alongside college sports pro…
    STAT · 16d agoNegative↗ source
  • Weighing the risks of CAR T in autoimmune disease as Kyverna nears market
    Not a month after reports of three deaths in autoimmune trials for Novartis' CAR T cell therapy ignited a debate about the use of these treatments in nonfatal diseases, Kyverna Therapeutics reporte…
    BioSpace · 16d ago↗ source