FDA Related News

Medical Devices

Medline Recalls Craniotomy Kits

Medline Industries recalls (Class 1 device correction) certain lots of its Craniotomy Kits containing recalled Codman Disposable Perforators 14mm, whi...

Human Drugs

FDA Priority Review for Sprouts Addyi sNDA

FDA will give priority review to a Sprout sNDA to expand the indication for Addyi to treat low sexual desire in post-menopausal women.

Biologics

FDA to Demand New Elevidys Safety Data from Sarepta

FDA reportedly is requiring additional safety data from Sarepta Therapeutics before the agency considers supporting use of the companys Duchenne muscu...

Human Drugs

Positive Trial Data on Sleep Apnea Drug

Apnimed announces positive topline results from its second pivotal Phase 3 trial of AD109 (aroxybutynin and atomoxetine), a once-daily oral pill for t...

FDAs Elsa Hallucinates Confidently: Report

Gizmodo reports that FDA employees who have used Elsa told CNN the AI tool makes up reports and hallucinates confidently.

Medical Devices

Baxter Recalls Mobile Lift Component

Baxter Healthcare recalls (Class 1) a mobile lift component used in several patient lift devices due to the risk of improper attachment.

Biologics

RFK Jr. OKs Directive to Ban Thimerosal in Flu Shots

HHS secretary Robert F. Kennedy, Jr. approves a new federal directive removing thimerosal, a mercury-based preservative, from all influenza vaccines d...

Human Drugs

FDA Soliciting CNPV Pilot Interest

FDA solicits statements of interest in being one of no more than five drug and biologic developers to participate in the initial cohort for the Commis...

Human Drugs

Few ODAC Advisory Committee Questions Difficult: Study

University researchers say they found relatively few instances in which Oncology Drugs Advisory Committee members reported difficulty in voting on a q...

Human Drugs

FDA SSDC White Paper Out

CDER issues a white paper tracing the history of selective safety data collection (SSDC) and plans for the future.