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  • 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
  • GSK licenses Chimagen trispecific T-cell engager for up to $750 million, targeting phase-1 multiple myeloma study
    GSK has entered a licensing agreement with China’s Chimagen Biosciences that could be worth as much as $750 million. The deal will allow GSK to begin phase‑1 testing of a trispecific T‑cell engager…
    Fierce Biotech · 1mo agoDealPositive↗ source
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globenewswire health73
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Nephrology676
  • 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
  • New antibody-drug conjugates show promise as potential standard for extensive-stage small cell lung cancer at WCLC 2026
    The World Conference on Lung Cancer showcased several late‑stage trial updates, with a focus on new therapies for small cell lung cancer, the more aggressive form of the disease. Antibody‑drug con…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ 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
  • Vera Therapeutics reports two-year data showing Trutakna stabilizes kidney function in IgA nephropathy, paving way for full FDA approval
    Vera Therapeutics announced that its recently approved drug Trutakna has produced encouraging two-year results in patients with IgA nephropathy, a chronic autoimmune kidney disease. The data indic…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • RegCell secures multi-million dollar Series A to advance Nobel-winning regulatory T-cell therapy
    RegCell, a biotech founded by Nobel laureate Shimon Sakaguchi, announced a new financing round to move its regulatory T-cell (Treg) program toward clinical testing. The company’s CEO Michael McCul…
    Endpoints · 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 approves Telix's Pixclara, first FET-PET imaging drug for glioma in the U.S.
    The U.S. Food and Drug Administration has granted approval to Telix Pharmaceuticals' Pixclara, a fluorine‑18 labeled amino acid PET tracer designed for imaging gliomas. This marks the first FDA‑cle…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • Johnson & Johnson’s depression drug JNJ-5120 fails primary endpoint in phase 2 trial
    A phase 2 study of JNJ-5120, an M1 receptor antagonist developed by Johnson & Johnson with Contineum Therapeutics, did not meet its primary efficacy endpoint in patients with major depressive disor…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Medtronic and Given Imaging recall Bravo CF esophageal pH monitoring capsule delivery devices
    Medtronic and its subsidiary Given Imaging have issued a recall of the Bravo CF esophageal pH monitoring capsule delivery devices after reports that the capsules may fail to attach or detach from t…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Sling Therapeutics raises $123M Series C to advance oral thyroid eye disease drug into Phase 3
    Sling Therapeutics announced a $123 million Series C financing round aimed at moving its oral therapy for thyroid eye disease into a late‑stage trial and eventual market launch. The company has be…
    Fierce Biotech · 1mo agoDealPositive↗ 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 launches expedited IND pilot program, integrating public feedback into qualification criteria
    The FDA announced that its long-awaited expedited investigational new drug (IND) pilot program has started accepting applications as of Tuesday. Agency leaders Karim Mikhail and Michael Davis, new…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Axoltis reports Phase 2 failure of experimental ALS drug but notes small signal
    Axoltis Pharma, a French biotech, announced that its Phase 2 trial of an experimental ALS therapy did not meet its primary endpoints. The company said the data were noisy but observed a modest tre…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • FDA launches pilot to accelerate early-stage drug trials in the United States
    The FDA announced a new pilot program called the Expedited Investigational New Drug Pilot as part of Operation Trialblazer. The initiative will pair up to ten qualified research institutions with…
    BioPharma Dive · 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
  • Stakeholders call on FDA to set safety and treatment standards for emerging psychedelic therapies
    At a recent public hearing, experts and other stakeholders emphasized the need for clear safety and access guidelines as psychedelic medicines move closer to market. The FDA is intensifying effort…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • FDA Opens Expedited IND Pilot to Speed First-in-Human Trials, Applications Accepted Through Oct. 30
    The U.S. Food and Drug Administration announced the final design of an Expedited IND Pilot aimed at shortening the time from drug discovery to first-in-human trials. The pilot pairs drug developer…
    fda press · 1mo agoRegulatoryNeutral↗ source
  • Cullinan-Taiho eye FDA filing for zipalertinib after trial shows strong PFS benefit despite three deaths
    Cullinan Therapeutics and its partner Taiho Oncology said they will seek FDA approval for zipalertinib, an oral therapy for a subset of non‑small cell lung cancer, based on data from a late‑stage s…
    BioSpace · 1mo agoPositive readoutNeutral↗ source
  • FDA opens pilot to accelerate phase 1 trials with fast IND reviews
    The Food and Drug Administration announced a new pilot program aimed at speeding up early-stage clinical trials in the United States. The initiative pairs drug sponsors with qualified research inst…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • New documents expose flaws in Medicare’s rushed AI prior-authorization pilot
    New internal documents have highlighted serious shortcomings in Medicare’s recently launched AI-driven prior‑authorization pilot, which was rolled out faster than anticipated. The pilot, designed…
    STAT · 1mo agoRegulatoryNegative↗ source
  • J&J and Contineum's oral M1 inhibitor fails second mid-stage depression trial
    Contineum Therapeutics and Johnson & Johnson reported that their oral M1 receptor inhibitor, known as PIPE-307 or JNJ-5120, did not meet its primary endpoints in a Phase II study for major depressi…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Exercise and echocardiograms helped keep astronauts’ hearts stable during six-month spaceflight, study finds
    A team of international researchers examined 13 astronauts who spent six months aboard the International Space Station. The crew underwent regular onboard echocardiograms to monitor heart size and…
    STAT · 1mo agoPositive readoutPositive↗ source