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FDA OKs Chiesis Lamzede for Alpha-Mannosidosis

[ Price : $8.95]

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FDA publishes a draft guidance with information on requesting and conducting product-specific guidance meetings between FDA and AN...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

2 Meetings on Adverse Event Reporting

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Federal Register notice: FDA announces two public meetings on electronic submission of adverse event reports using International C...

GE Recalls Unstable Nuclear Medicine Devices

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GE HealthCare recalls its Nuclear Medicine 600 and 800 Series systems after identifying an issue with two mechanisms that prevent ...

Drug R&D Cant Justify High Prices: Study

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UK-based researchers say their analysis of drug company financial records doesnt support company claims that high drug prices are ...