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CRL for Amgen Lumakras sNDA

[ Price : $8.95]

FDA requires an additional postmarketing confirmatory study for full approval of Amgens Lumakras non-small cell lung cancer treatm...

NEWSROOM CLOSED FOR THE HOLIDAYS

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FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Tuesday, January 2, 2024.

FDA OKs Merck Kidney Cancer Drug

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FDA approves a Merck NDA for Welireg (belzutifan) for treating patients with advanced kidney cancer following a programmed death r...

FDA OKs Glaukos Intraocular Pressure Drug Implant

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FDA approves a Glaukos Corp. NDA for iDOSE TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for reduc...

2 Imbruvica Accelerated Approvals Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of the indications for mantle cell lymphoma and marginal zone lymphoma for Pharmac...

DTC Survey Examines Quantitative Claims

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Federal Register notice: FDA sends to OMB an information collection proposal entitled A Survey on Quantitative Claims in Direct-to...

FDA Updates Breast Implant Safety Info

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FDA updates its Risks and Complications of Breast Implants Web page that clarifies information about implant removal and adds ultr...

Guide on Priority Zoonotic Animal Drugs

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FDA posts a draft guidance entitled Priority Zoonotic Animal Drug (PZAD) Designation and Review Process.

Moderna Inspection Cites GMP Issues: Report

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FDA investigators cite five GMP issues during a September inspection at Modernas primary facility in Norwood, MA, according to a R...

FDA Warns Makers of Illegal Animal Antimicrobials

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FDA sends Warning Letters to nine manufacturers and distributors of misbranded unapproved animal antimicrobial drugs.