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FDA General

18,000 Appalled Physicians Urge Senate Rejection of RFK Jr.

Over 18,000 appalled physicians sign an open letter urging the U.S. Senate to reject the nomination of Robert F. Kennedy Jr. to serve as HHS secretary...

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Human Drugs

FDA Accepts NDA for Menkes Disease Drug

FDA accepts for review a Fortress Biotech NDA for CUTX-101 (copper histidinate) for treating Menkes disease.

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Human Drugs

Tenpoint Therapeutics Positive Data on Vision Drug

Tenpoint Therapeutics reports positive topline results from BRIO-II, the companys second Phase 3 pivotal trial evaluating Brimochol PF (brimonidine) f...

Medical Devices

CapsoVision Capsule Endoscopy Home Use Cleared

FDA clears a CapsoVision 510(k) for its CapsoCam Plus capsule endoscopy system for remote ingestion.

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Human Drugs

Pfizer Touts Bladder Cancer Drug Data

Pfizer reports positive topline results from its pivotal Phase 3 CREST trial evaluating sasanlimab for combination use with Bacillus Calmette-Gurin in...

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Federal Register

Vertex Cystic Fibrosis NDA Used Priority Voucher

Federal Register notice: FDA announces that a priority review voucher was used with the agencys 12/20/2024 approval of Vertex Pharmaceuticals Alyftrek...

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Human Drugs

FDA to Review Agios Pyrukynd sNDA

FDA says it will review an Agios sNDA for a new Pyrukynd indication and sets a 9/7 PDUFA action date.

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Human Drugs

FDA Puts Marengos Invikafusp on Fast Track

FDA grants fast track designation to Marengos invikafusp T cell activator for some colorectal cancers.

Medical Devices

FDA Clears ZuriMED Rotator Cuff Reinforcer

FDA clears a ZuriMED Technologies 510(k) for the FiberLocker System for rotator cuff repair reinforcement.

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Federal Register

Priority Voucher Awarded to Neurocrine Biosciences

Federal Register notice: FDA announces it has issued a priority review voucher to Neurocrine Biosciences because its 12/13 NDA approval for Crenessity...