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Regulatory Intelligence & Drug Approvals1 month agoNovo pursues long-acting obesity drugs; Acadia slumps on Alzheimer’s data
Novo’s latest alliance involves injectables given every one to three months. Elsewhere, Nektar won a legal spat with Eli Lilly and the FDA issued two approvals.
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Regulatory Intelligence & Drug Approvals1 month agoEU clears first drug therapy for rare disease cALD
Neuraxpharm and Minoryx' Nezglyal has become the first approved drug therapy in the EU for rare neurodegenerative disease cALD.
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Regulatory Intelligence & Drug Approvals1 month agoFairyGene, Inc. – 726976 – 07/31/2026
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
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Regulatory Intelligence & Drug Approvals1 month agoFDA starts speedy review of Imfinzi in bladder cancer
AstraZeneca is closing on FDA approval of a new bladder cancer indication for Imfinzi that could help to fend off encroachment from MSD's Keytruda.
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Regulatory Intelligence & Drug Approvals1 month agoFDA nominee Overton dodges questions on Trump influence
Trump's FDA nominee Heidi Overton was quizzed on a range of issues at her Senate hearing, including vaccines, the abortion pill, and agency reforms.
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Regulatory Intelligence & Drug Approvals1 month agoFDA approves Lilly’s Onswik for type 2 diabetes in adults
This treatment is approved for use alongside diet and exercise to improve blood sugar control. Onswik is intended to provide steady basal insulin levels for seven...
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Regulatory Intelligence & Drug Approvals1 month ago
U.S. FDA Approves Welireg (belzutifan) Plus Lenvima (lenvatinib) for Certain Previously Treated Adult Patients With Advanced Renal Cell Carcinoma With a Clear Cell Component (ccRCC)
RAHWAY, N.J. & NUTLEY, N.J.--(BUSINESS WIRE) September 25, 2026 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today...
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Regulatory Intelligence & Drug Approvals1 month ago
FDA Approves Atebrioz (zilurgisertib) for Adult and Pediatric Patients with Fibrodysplasia Ossificans Progressiva
FOSTER CITY, Calif. & WILMINGTON, Del.--(BUSINESS WIRE) September 25, 2026 -- Mirum Pharmaceuticals, Inc. (Nasdaq:MIRM) and Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug...
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Regulatory Intelligence & Drug Approvals1 month agoOverton vows speed, deference to staff reviews, if confirmed to lead FDA
BIOCENTURY | POLITICS, POLICY & LAWOVERTON VOWS SPEED, DEFERENCE TO STAFF REVIEWS, IF CONFIRMED TO LEAD FDAThe commissioner nominee faced sharp questions about vaccines, abortion drugs,...
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Regulatory Intelligence & Drug Approvals1 month agoGrail multicancer detection test wins FDA advisers’ backing
Panel members said the first-of-a-kind blood test should not be used to replace medical guideline-recommended cancer screenings, however.
Opentrons Raises $40M in Series E to Expand Its Robotics, Software, Data Infrastructure
100 Million-Cell AI-Ready Dataset with Single-Cell and Proteomic Data Created by Parse and Nomic
No Nonsense: David Liu Lauds Progress in Disease-Agnostic Gene Editing at ESGCT
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
