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Bausch + Lomb Recalls enVista Intraocular Lenses

[ Price : $8.95]

Bausch + Lomb recalls all enVista intraocular lenses due to increasing adverse event reports of toxic anterior segment syndrome as...

Axsome Solriamfetol Misses Primary Endpoint

[ Price : $8.95]

Axsome Therapeutics says its solriamfetol missed the primary endpoint in a Phase 3 proof-of-concept trial to treat major depressiv...

Compass Therapeutics Reports on Tovecimig Trial Data

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Compass Therapeutics reports statistically significant top-line data on the primary efficacy endpoint from its COMPANION-002 trial...

3 Observations on SKNV Outsourcing FDA-483

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FDA releases the form FDA-483 with three observations from an inspection at the Pompano Beach, FL-based SKNV outsourcing facility.

Multiple Violations in Next Science Inspection

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FDA warns Jacksonville, FL-based Next Science that it is illegally manufacturing and distributing adulterated and misbranded medic...

FDA in Upheaval as Staff Layoffs Begin

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HHS begins terminating FDA employees, with many receiving email notifications in the early morning hours or being denied entrance ...

Apellis Files Empaveli sNDA in Rare Kidney Diseases

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FDA accepts for priority review an Apellis Pharmaceuticals supplemental NDA for Empaveli (pegcetacoplan) for treating two severe a...

RFK Jr. Upends His Promise to Enhance Transparency

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Despite HHS secretary Robert F. Kennedy, Jr.s promises to boost transparency at HHS and its health agencies, staff cuts now occurr...

Marks Firing Challenges RFK Jr.s Fitness for Office

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FDA Webview editor Jim Dickinson analyzes the firing of CBER director Peter Marks and finds it a challenge to HHS secretary and va...

Corcepts Relacorilant Shows Promise in Ovarian Cancer

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Corcept Therapeutics says data from its pivotal Phase 3 ROSELLA trial demonstrated that relacorilant in combination with nab-pacli...