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Biologics

FDA Approves Moderna Covid Vaccine sBLA

FDA approves a Moderna sBLA for its Spikevax Covid-19 vaccine for children aged six months to 11 years old who are at increased risk for Covid-19.

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Human Drugs

Rhythm Reports Positive Data on Obesity Drug

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

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Medical Devices

Exactech Equinoxe Scapula Reconstruction Device Cleared

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

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Human Drugs

FDA Mifepristone Restrictions are Legal: Judge

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

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Medical Devices

AirLife/Vyaire Recall Infant Heated Wire Circuits

AirLife and Vyaire recall certain infant heated wire circuits due to the risk that accessory adapters may unintentionally disconnect during setup or u...

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Human Drugs

Trethera Gets Fast Track for Prostate Cancer Drug

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

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Human Drugs

FDA OKs Updated Dosing for Lillys Alzheimer's Drug

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

Human Drugs

CGMP, Other Violations at Dynamic Blending

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

Human Drugs

Libby Laboratories CGMP Issues

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

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Medical Devices

Device AI Facts Labeling Needed: Paper

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