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  • 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
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Pain656
Nephrology645
  • 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 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 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
  • Mayo Clinic and Thermo Fisher launch Precure to build large biomedical data set
    Mayo Clinic has partnered with Thermo Fisher Scientific to form Precure LLC, a new group focused on creating one of the largest biomedical data sets using human multi‑omics data. Precure will inte…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Eli Lilly partners with QurCan Therapeutics, pledging up to $237 M per CNS genetic-medicine program
    Eli Lilly announced a collaboration with Canadian biotech QurCan Therapeutics to advance genetic medicines aimed at the central nervous system. Under the deal, Lilly will provide up to $237 millio…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Sionna Therapeutics cuts 46% of staff after cystic fibrosis trial miss
    Sionna Therapeutics announced it will lay off roughly half of its employees as it reassesses its strategy following a recent setback in its cystic fibrosis program. The company’s lead candidate, S…
    Fierce Biotech · 1mo agoLayoffsNegative↗ source
  • FDA launches pilot program to speed early-phase drug trials
    The U.S. Food and Drug Administration announced a new pilot program aimed at accelerating the review of Phase 1 clinical trials for investigational new drugs. The initiative introduces a rolling s…
    raps · 1mo agoRegulatoryPositive↗ source
  • Experts urge FDA to establish safety and access guidelines for psychedelic drugs; GSK to close German vaccine plant
    Experts are urging the U.S. Food and Drug Administration to set clear safety and access standards for psychedelic medicines, according to the briefing. The request reflects growing interest in the…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Connect Biopharma's asthma drug rademikibart misses primary endpoint in Phase 2 trial
    Connect Biopharma reported that its IL-4/IL-13 blocker rademikibart failed to meet the primary endpoint in a Phase 2 study in asthma patients with type-2 inflammation. The trial enrolled 160 patie…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Novo abandons $285 million partnership with Ascendis for monthly GLP-1 obesity drug
    Novo Nordisk, which recently rebranded, has terminated a licensing agreement with Ascendis Pharma that was originally valued at up to $285 million. The collaboration, signed in November 2024, was…
    Fierce Biotech · 1mo agoDealNegative↗ source
  • FDA issues warning letters to Bausch & Lomb and Indian API maker over GMP lapses
    The U.S. Food and Drug Administration sent warning letters to two companies after finding violations of good manufacturing practice. Bausch & Lomb, which produces ophthalmic products, was cited f…
    raps · 1mo agoRegulatoryNegative↗ source
  • Jaguar LAA acquires Johnson & Johnson's Laminar atrial fibrillation device assets
    Jaguar LAA, a newly formed medtech company, announced it has purchased assets related to Johnson & Johnson's Laminar atrial fibrillation device program. The Laminar technology is a catheter‑based…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Experts review five decades of regulatory evolution at RAPS Convergence 2026
    At the opening plenary of RAPS Convergence 2026 in Charlotte, NC, specialists in medical device and pharmaceutical regulatory affairs gathered to discuss the field’s trajectory. They reflected on…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Summit and Akeso report ivonescimab extends lung cancer survival by eight months versus Keytruda in Phase 3 trial
    Summit Therapeutics and its partner Akeso said their experimental dual-target drug ivonescimab added about eight months of overall survival for patients with lung cancer compared with Merck's Keytr…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • AstraZeneca’s newly approved pill fails frontline breast cancer study
    Etcamah is the second oral “SERD” to recently fall short in first-line breast cancer, following a similar setback from Roche earlier this year.
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • FDA approves Scholar Rock's muscle-targeted SMA therapy Isembyld
    The Food and Drug Administration has approved a new medication for spinal muscular atrophy (SMA). The drug, apitegromab marketed as Isembyld, is the first muscle-targeted therapy for the disease.…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • FDA holds hearing on access and safety as psychedelic drug approval looms
    The Food and Drug Administration convened a public hearing to collect input on how emerging psychedelic medicines should be used, monitored, and continuously studied as a potential first approval a…
    Fierce Biotech · 1mo agoRegulatoryNeutral↗ source
  • Corbus reports phase 1b obesity data showing lower neuropsychiatric side effects for CB1 antagonist
    Corbus Pharmaceuticals released results from a phase 1b trial of its CB1 inverse agonist aimed at treating obesity. The study indicated the drug lowered rates of depression, anxiety, irritability a…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Cellectis drops its allogeneic CAR-T candidates lasme-cel and eti-cel amid rising competition from in-vivo therapies
    Cellectis announced it is terminating development of its two allogeneic CAR-T programs, lasme-cel for B-cell acute lymphoblastic leukemia and eti-cel for non-Hodgkin lymphoma. The move reflects a…
    Fierce Biotech · 1mo agoNegative↗ source
  • Cellectis abandons CAR-T programs, shifts focus to in vivo gene editing
    Cellectis announced it will discontinue its donor-derived CAR‑T programs and redirect its efforts toward in vivo gene‑editing medicines. The company said the commercial and clinical landscape for…
    BioPharma Dive · 1mo agoNegative↗ source
  • Eli Lilly halts early-stage obesity drug LY4064912 after failing to meet development criteria
    Eli Lilly announced it is ending development of its early-stage obesity candidate, LY4064912, after the phase 1 study did not achieve the company’s expectations. The first‑in‑human trial enrolled…
    Fierce Biotech · 1mo agoNegative↗ source
  • Electra Therapeutics targets up to $342M IPO to fund phase 2/3 study of ipsoprubart for rare inflammatory syndrome
    Electra Therapeutics, based in South San Francisco, filed with the SEC indicating plans to sell 21.7 million shares at $14‑$16 each. The company expects net proceeds of about $296.6 million, poten…
    Fierce Biotech · 1mo agoDealNeutral↗ source