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FDA+ channel feed
FDA rejects liver cancer drug combo, shares of Korean biotech tank
11 months ago
R&D
Q&A: FTC’s top healthcare enforcer on pharma M&A, company growth and PBMs
11 months ago
Deals
Pharma
FDA approves Amgen’s T cell engager in aggressive form of lung cancer
11 months ago
Pharma
House panel advances bills targeting rare disease, priority review vouchers
11 months ago
Pharma
Bristol Myers' CAR-T therapy Breyanzi adds follicular lymphoma to list of approvals
11 months ago
Pharma
Cell/Gene Tx
WHO greenlights Takeda's dengue vaccine as company plans to 're-engage' with FDA
11 months ago
Pharma
As adcomm looms, ICER raises questions over Lykos’ MDMA studies
11 months ago
Pharma
Eisai heads to FDA with subcutaneous version of Alzheimer’s treatment developed with Biogen
12 months ago
Pharma
Ascendis’ hypoparathyroidism drug saddled with three-month delay at FDA
12 months ago
Pharma
Destruction of documents, insufficient data lead FDA to reject hep B vaccine update
12 months ago
Pharma
FDA offers more clarity on safety testing for cell therapies
12 months ago
Cell/Gene Tx
WHO members miss deadline for pandemic accord draft, will continue talks
12 months ago
Pharma
New Biosecure draft features 2032 grandfather clause, five-year grace period for added companies
12 months ago
China
Pharma
Senators question Chamber of Commerce's motives around march-in rights
12 months ago
Pharma
Corrected: Experts to decide within a year whether to recommend Duchenne muscular dystrophy for newborn screening
Last year
Ahead of likely approval, ICER finds Geron’s imetelstat is not cost-effective at $250,000 annually
Last year
Pharma
House panel marks up bill to require PBMs to use a flat fee in Medicare
Last year
Pharma
Senate appropriators question FDA commissioner on H5N1 virus prep
Last year
White House unveils long-awaited policy on overseeing research of concern
Last year
Pharma
House Oversight chair presses FDA on China amid growing tensions
Last year
China
Lilly gets June adcomm for Alzheimer's drug donanemab, following earlier delay
Last year
Sen. Cassidy calls on Biden to do better at sharing H5N1 bird flu information
Last year
Pharma
Industry groups critique new guidance for Medicare drug price negotiations in 2027
Last year
Pharma
Remodeling REMS: FDA kicks off guidance series with draft on new framework
Last year
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