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Lantheus/Progenics sNDA Approved for Vialmix RFID

[ Price : $8.95]

FDA approves a Lantheus and Progenics Pharmaceuticals supplemental NDA for Vialmix RFID for Definity.

Alert on Compounded Moxifloxacin Ophthalmic Solutions

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An FDA drug safety alert warns about reports of toxic anterior segment syndrome following intraocular administration of compounded...

MagVenture TMS Therapy Cleared for OCD

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FDA clears a MagVenture 510(k) for its TMS Therapy as an adjunct treatment for obsessive-compulsive disorder.

FDA Accepts Regeneron BLA for Priority Review

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FDA says it will give priority review to Regenerons BLA for evinacumab as an adjunct treatment in patients with homozygous familia...

Vaccines Panel to Discuss 2021 Flu Vaccine

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Federal Register notice: FDA announces a 10/2 Vaccines and Related Biological Products Advisory Committee meeting that will discus...

Marketing Status Notifications Guidance

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Federal Register notice: FDA makes available a final guidance entitled Marketing Status Notifications Under Section 506I of the Fe...

FDA Finds Multiple Violations in Mexican Hand Sanitizers

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FDA warns Mexicos Soluciones Cosmeticas that it distributed unapproved adulterated and misbranded hand sanitizers that contained m...

Fennec Pharma Complete Response on Pedmark

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FDA issues Fennec Pharmaceuticals a complete response letter on its NDA for Pedmark (sodium thiosulfate), for preventing ototoxici...

CGMP Violations at Taka USA

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FDA warns Taka USA about CGMP violations in its production of finished pharmaceuticals.

Over 200 Covid Tests Authorized Through EUA

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FDA says that over 200 SARS-CoV-2 tests have been approved through emergency use authorizations, with hundreds more in the pipelin...