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BCG Treatment Development Guidance

[ Price : $8.95]

FDA publishes a draft guidance on developing drug and biological treatments for a specific bladder cancer.

FDA OKs Cutaneous T-cell Lymphoma Therapy

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FDA approves a Citius Pharmaceuticals BLA for Lymphir (denileukin diftitox-cxdl) for treating relapsed or refractory cutaneous T-c...

Purdues Opioid-Reversing Injector Approved

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FDA approves a Purdue Pharma NDA for Zurnai, a nalmefene hydrochloride auto-injector for the emergency treatment of known or suspe...

Panel to Review Urinary Tract Infection NDA

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Federal Register notice: FDA announces a 9/9 Antimicrobial Drugs Advisory Committee meeting to discuss an Iterum Therapeutics NDA ...

OTC Monograph Admin Order Comments Extended

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Federal Register notice: FDA reopens the comment period for its proposed administrative order entitled Amending Over-the-Counter M...

FDA to Survey Healthcare Providers

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The CDER Office of Prescription Drug Promotion releases plans to survey 2,400 healthcare providers on several issues relating to p...

Servier Gets OK for Brain Tumor Drug

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FDA approves a Servier Pharmaceuticals NDA for Voranigo (vorasidenib) for treating certain adult and pediatric patients 12 years a...

Data Integrity is Biggest Inspection Issue: FDA

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CDER compliance officer Yasamin Ameri says FDA will issue about the same number of drug CGMP Warning Letters in 2024 as in 2023.

Enforce Regulation of Wellness Devices: Petition

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Spark Biomedical, a manufacturer of an FDA-approved neurostimulation device, asks the agency to ensure that unapproved neurostimul...

FDA Cites Krazati Provider Web Page

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The CDER Office of Prescription Drug Promotion says a Mirati Therapeutics provider Web page for Krazati makes false and misleading...