FDA Related News

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

Abivax Favorable Data in Ulcerative Colitis Trials

Abivax announces favorable topline results from two pivotal Phase 3 induction trials of its investigational oral therapy obefazimod (ABX464) in modera...

Marketing

Bill to Require Drug Price in DTC Ads

Five House members introduce a bill to require DTC television ads to include the drugs list price.

Human Drugs

Gilead Sciences Settlement Helps 49 States

Pennsylvania attorney general Dave Sunday says 49 states are sharing a $202 million settlement with Gilead Sciences to resolve charges that the compan...

Human Drugs

Stakeholder Suggestions for PDUFA Reauthorization

Two stakeholders urge FDA to use the PDUFA 8 reauthorization to emphasize the need for congressional funding and take steps to improve transparency an...

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...