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FDA to Review Iveric NDA for Avacincaptad Pegol

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FDA accepts an Iveric Bio NDA for avacincaptad pegol for priority review with a Breakthrough Therapy designation to treat geograph...

Comments Sought on WHO Drug Scheduling

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Federal Register notice: FDA provides an opportunity to submit written comments on recommendations by the World Health Organizatio...

Eisai Expects FDA to Approve Alzheimers Drug Soon

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Eisai CEO Ivan Cheung says he expects full FDA approval for the early Alzheimers drug Leqembi by this summer if the agency gives t...

FDA OKs Chiesis Lamzede for Alpha-Mannosidosis

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FDA approves Chiesis Lamzede to treat some manifestations of alpha-mannosidosis in adults and children.

FDA Withdraws Miles Laboratories ANDA

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Federal Register notice: FDA withdraws a Miles Laboratories ANDA for alcohol and dextrose injection, 5 mL/100 mL because the agenc...

Product-Specific Guidance Meetings

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FDA publishes a draft guidance with information on requesting and conducting product-specific guidance meetings between FDA and AN...

Califf Sees Misinformation as Cause of Preventable Deaths

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FDA commissioner Robert Califf announces a project to explore ways the agency can respond to and counter misleading health informa...

Zephyrus Safety Syringe Cleared

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FDA clears a Zephyrus Innovations 510(k) for its Aerojec 3ml safety syringe.

FDA OKs Apellis Syfovre for Geographic Atrophy

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FDA approves Apellis Pharmaceuticals Syfovre to treat geographic atrophy secondary to age-related macular degeneration.

Guide on Compounding Ibuprofen Oral Suspension

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Federal Register notice: FDA makes available a final guidance on compounding certain ibuprofen oral suspension products.