FDA Related News

Human Drugs

Roche Reports Mixed Data on COPD Studies

Roche reports mixed data on its investigational chronic obstructive pulmonary disease drug astegolimab in two key late-stage clinical trials.

Medical Devices

Maquet Servo Ventilators in Class 1 Recall

Maquet Critical Care recalls (Class 1) its Servo Ventilator Systems to update their use instructions due to the risk of inaccurate compliance measurem...

Biologics

FDA Mulls Pulling Sareptas Gene Therapy

An HHS official says FDA is taking a hard look at pulling from the market Sarepta Therapeutics gene therapy Elevidys (delandistrogene moxeparvov...

Animal Drugs

Guide on Biosimilar Formal Meeting Requsts

FDA releases a final guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.

Medical Devices

SunMed Manual Resuscitators Recalled

SunMed Holdings recalls its Adult Manual Resuscitator devices due to incorrect assembly of the bacterial/viral filter.

Marketing

Sen. Durbin Calls for Crackdown on DTC Telehealth

Senator Dick Durbin (D-IL) calls for a crackdown on pharmaceutical companies growing use of direct-to-consumer telehealth platforms due to concerns ab...

Human Drugs

ICH Guide on Including Pregnant Women in Trials

FDA posts an International Conference on Harmonization draft guidance entitled E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials.

Human Drugs

FDA Rejects Genentechs Bid to Expand Columvi Use

FDA rejects Genentechs bid to broaden the use of its lymphoma drug Columvi.

Human Drugs

Panel Votes Down Rexulti for PTSD

FDAs Psychopharmacologic Drugs Advisory Committee votes against approving an Otsuka Pharma NDA for Rexulti (brexpiprazole) when used in combination wi...

FDA AI Moves Raise Questions: Attorneys

Three Akin attorneys say regulated industry continues to have questions about FDA actions in launching an internal artificial intelligence tool and ap...