FDA Related News

Human Drugs

Contaminated SinuCleanse Nasal Wash Recalled

Ascent Consumer Products recalls one lot of its SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System following a confirmed test result of microbial c...

Human Drugs

OTC Shampoo Suit Preempted by FDA Monograph

Two Hollingsworth attorneys write in a Washington Legal Foundation post about a California federal court decision tossing state claims against an over...

Biologics

Janssen Vaccines FDA-483

FDA releases the form FDA-483 with five observations from an inspection at the Janssen vaccine manufacturing facility in Incheon, South Korea.

Detailed Comments on Protocol Deviations Draft Guide

Labcorp and AstraZeneca submit line-by-line comments on an FDA draft guidance on clinical investigation protocol deviations.

Biologics

Precigen BLA for Respiratory Papillomatosis Therapy

FDA accepts for priority review a Precigen BLA for PRGN-2012 (zopapogene imadenovec), an investigational adenoverse gene therapy for treating adults w...

Human Drugs

Entrada Clinical Hold Lifted on Duchenne Drug

FDA lifts a 12/2022-ordered clinical hold on Entrada Therapeutics Duchenne muscular dystrophy therapy ENTR-601-44 and provided authorization to begin ...

Human Drugs

Ex-CDER Head Cavazzoni Rejoins Pfizer

Former CDER director Patrizia Cavazzoni rejoins Pfizer as the companys chief medical officer.

Human Drugs

Medtronics Brain Stimulator for Parkinsons Approved

FDA approves a Medtronic PMA for its BrainSense Adaptive deep brain stimulation and BrainSense Electrode Identifier for use in Parkinsons patients.

Human Drugs

FDA Trying to Rehire 300 Staff Recently Fired

FDA moves over the weekend to rehire up to 300 scientists and reviewers who were terminated last week as part of the Trump Administrations cost-cuttin...

Human Drugs

No Panel Meeting for Brensocatib NDA

FDA tells Insmed that it does not currently plan to hold an advisory committee meeting to discuss the companys NDA for brensocatib for patients with n...