FDA Related News

Human Drugs

Fire CDER, OGD Directors: Members of Congress

Thirteen Republican House members call on HHS to lay off the CDER director, Office of Generic Drugs director, and others who were behind the approval ...

Medical Devices

FDA Clears Trial Restart of Recurring Stroke Device

FDA clears restart of a pivotal clinical trial evaluating the NobleStitch EL system, a device-free, suture-mediated method for closing a patent forame...

Human Drugs

Boehringers Jascayd OKd for Pulmonary Fibrosis

FDA approves a Boehringer Ingelheim NDA for Jascayd (nerandomilast) tablets for treating idiopathic pulmonary fibrosis.

Statistical Analysis of FDA Warning Letters

A Hyman, Phelps & McNamara statistical analysis of FDA Warning Letters published by FDLI shows that nearly three-quarters of Warning Letters are issue...

Medical Devices

FDA Warns Technological Medical

FDA warns West Palm Beach, FL-based Technological Medical Advancement about Quality System violations in its production of two unapproved laser system...

Human Drugs

Multiple Creative Essences Violations

FDA warns Santa Fe Springs, CA-based Creative Essences about CGMP violations in its production of misbranded unapproved drugs.

Biologics

FDA Outlines Quicker Path for Lexeo Gene Therapy

FDA input offers Lexeo Therapeutics a potential accelerated approval pathway for its investigational gene therapy LX2006.

Human Drugs

Former CBER Head Marks Joins Eli Lilly

After being forced to resign in April, former CBER director Peter Marks accepts a job at Lilly Research Laboratories overseeing molecule discovery and...

Human Drugs

Clinical Hold Lifted on Neurizon ALS Drug

FDA lifts a clinical hold on Neurizon Therapeutics on its lead experimental treatment for amyotrophic lateral sclerosis.

Human Drugs

Priority Review for Orca Blood Cancer Cell Therapy

FDA accepts for priority review an Orca Bio BLA for Orca-T, an investigational allogeneic T-cell immunotherapy for patients with certain blood cancers...