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MagVenture TMS Therapy Cleared for OCD

[ Price : $8.95]

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

[ Price : $8.95]

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

FDA Releases 1st Essure Adverse Event Spreadsheet

[ Price : $8.95]

FDA releases the first monthly spreadsheet submitted by Bayer on adverse events for its Essure birth control device.

Vaccines Panel to Discuss 2021 Flu Vaccine

[ Price : $8.95]

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

Marketing Status Notifications Guidance

[ Price : $8.95]

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

[ Price : $8.95]

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

FDA Clears Life Spine Lumbar Spacer

[ Price : $8.95]

FDA clears a Life Spine 510(k) for the Plateau-X Ti Lateral Lumbar Spacer System.