FDA Related News

Federal Register

Investigational Covid19 Convalescent Plasma, Correction

Federal Register notice: FDA corrects a notice that published in the 9/21 Federal Register announcing the withdrawal of a final guidance entitled Inve...

Consultants Advice on How to Talk to FDA

The data intelligence consulting firm Govzilla posts information on how regulated companies should talk to FDA and listen when FDA talks.

Human Drugs

X4 Pharma Fast Track Status for Mavorixafor

FDA grants X4 Pharmaceuticals a Fast Track Designation for mavorixafor for treating adult patients with WHIM (Warts, Hypogammaglobulinemia Infections ...

Human Drugs

FDA Awards $16 Million in Rare Disease Treatment Grants

FDA awards $16 million in six grants to help in developing treatments for rare diseases.

Medical Devices

FDA No Longer Reviewing Covid LDT Emergency Use Submissions

CDRHs Timothy Stenzel tells a virtual town hall that under an HHS ruling FDA is declining to review new EUA submissions for Covid LDT tests and those ...

Human Drugs

Y-mAbs Therapeutics Gets Orphan/Rare Pediatric Status

FDA grants Y-mAbs Therapeutics an orphan drug designation and rare pediatric disease designation for its antibody nivatrotamab and its use in treating...

Medical Devices

GenMark EUA for ePlex Respiratory Pathogen Panel

FDA grants GenMark Diagnostics an Emergency Use Authorization for its ePlex Respiratory Pathogen Panel 2.

Human Drugs

Regeneron Seeks EUA Request for Trumps Covid Cure

Regeneron seeks an emergency use authorization for its experimental antibody cocktail that president Trump has called a coronavirus cure while applyin...

Human Drugs

Lilly Seeking Neutralizing Antibody Monotherapy EUA

Lilly asks FDA for an EUA for a monoclonal antibody used in Covid-19 monotherapy.

FDA General

FDA Chief Counsel on New Enforcement Precedent

FDA chief counsel Stacy Cline Amin tells FDLI that the Covid-19 emergency has offered the agency an opportunity to set a new legal precedent that will...