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  • 'Still a bull': Novo's CEO on honoring heritage and planning for the future amid corporate rebrand
    Novo CEO Mike Doustdar—tapped to breathe new life into the Danish drugmaker last year after losing GLP-1 marketing ground to chief rival Eli Lilly—isn’t one to make changes for the sake of change.
    Fierce Biotech · 1mo agoRegulatoryNeutral↗ 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
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  • Novartis to pay $125M for blood-brain barrier crossing platform
    Proceeds from the deal, which hands Novartis global rights to a technology developed by Sironax, will help advance three candidates that the startup says have “best-in-class” potential.
    BioPharma Dive · 1mo ago↗ source
  • Sling banks $123M for an experimental thyroid eye disease pill
    A confirmatory late-stage study is now also underway for what the startup is positioning as, potentially, the first oral alternative to approved injectables like Amgen's Tepezza and Viridian's Lumvoa.
    BioPharma Dive · 1mo ago↗ source
  • FDA approves first generic radioligand therapy for neuroendocrine tumors as Sionna announces major layoffs
    The U.S. Food and Drug Administration has cleared Bexlutry, the first generic version of Novartis’ Lutathera, marking the debut of a radioligand therapy that can be used for SSTR‑positive neuroendo…
    BioPharma Dive · 1mo agoApprovalNeutral↗ 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
  • 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
  • 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 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
  • 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
  • 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
  • Danone USA recalls So Delicious Dairy Free Salted Caramel Cluster frozen dessert pints over possible foreign material
    Danone USA announced a voluntary recall of its So Delicious Dairy Free Salted Caramel Cluster non-dairy frozen dessert pints. The recall applies to pints with best‑by dates on or before April 3, 2…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Gias Foods recalls bettergoods Italian Lemon Alfredo Fettuccine over possible Listeria contamination
    Gias Foods of New York announced a recall of two lots of its bettergoods Authentic Italian Lemon Alfredo Fettuccine after routine testing indicated a potential contamination with Listeria monocytog…
    fda recalls · 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