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Rhythm Reports Positive Data on Obesity Drug

[ Price : $8.95]

Rhythm Pharmaceuticals reports positive topline results from its Phase 2 trial evaluating bivamelagon in patients with acquired hy...

Exactech Equinoxe Scapula Reconstruction Device Cleared

[ Price : $8.95]

FDA clears an Exactech 510(k) for the Equinoxe Scapula Reconstruction System for treating acromial and scapular spine fractures.

FDA Mifepristone Restrictions are Legal: Judge

[ Price : $8.95]

A Washington federal judge says FDA acted lawfully in imposing restrictions on the availability of chemical abortion drugs mifepri...

AirLife/Vyaire Recall Infant Heated Wire Circuits

[ Price : $8.95]

AirLife and Vyaire recall certain infant heated wire circuits due to the risk that accessory adapters may unintentionally disconne...

Trethera Gets Fast Track for Prostate Cancer Drug

[ Price : $8.95]

FDA grants Trethera a fast track designation for TRE-515 for treating prostate cancer.

FDA OKs Updated Dosing for Lillys Alzheimer's Drug

[ Price : $8.95]

FDA approves an updated dosing schedule for Eli Lillys Alzheimers therapy Kisunla (donanemab-azbt) to reduce the risk of a known s...

CGMP, Other Violations at Dynamic Blending

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FDA warns Vineyard, UT-based Dynamic Blending Specialists about multiple violations in its work as a contract manufacturer of over...

Libby Laboratories CGMP Issues

[ Price : $8.95]

FDA warns Berkeley, CA-based Libby Laboratories about CGMP violations in its manufacturing of finished drugs.

Device AI Facts Labeling Needed: Paper

[ Price : $8.95]

University of Illinois law school scholar Sara Gerke calls for FDA to create AI Facts labeling for artificial intelligence-powered...

New FDA Guide Doesnt Stop Some Device Hacking: Paper

[ Price : $8.95]

A Foundation for Defense of Democracies paper calls on FDA to correct a gap in a recent guidance that makes in-use medical devices...