FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

Trump Orders Changes to Childhood Vaccine Recommendations

President Trump signs an executive order directing the federal government to develop what the White House calls "Gold Standard Childhood Vaccine Recom...

latest-news-card-1
Human Drugs

Tenaxs TNX-103 Misses Primary Endpoint in Phase 3 Trial

Tenax Therapeutics says its oral levosimendan candidate TNX-103 failed to meet the primary endpoint in a Phase 3 trial evaluating the treatment in pat...

latest-news-card-1
Human Drugs

ITM Receives FDA Complete Response Letter for Radiopharmaceutical

FDA sends ITM Isotope Technologies Munich SE a Complete Response Letter (CRL) for its investigational radiopharmaceutical for gastroenteropancreatic n...

latest-news-card-1
Human Drugs

FDA Flags Abiomed, Oscor Correction of Impella Catheter Introducers

Abiomed and manufacturing partner Oscor issue a correction (Class 1 recall) for certain catheter introducers used with Impella heart pumps after ident...

latest-news-card-1
Human Drugs

Ibrahim Appointed CDER Deputy Center Director

FDA appoints Sarah Ibrahim as CDER deputy center director for Regulatory Programs, a role she has been serving in an acting capacity since January.

latest-news-card-1
FDA General

Trump Administration Weighs Executive Order on Autism, Vaccines

The Trump administration considers an executive order addressing vaccines and autism as soon as next week.

latest-news-card-1
Human Drugs

Senators Introduce Prescription Information Modernization Act

Senators Jim Banks (R-IN) ) and Cory Booker (D-NJ) introduce the bipartisan Prescription Information Modernization Act to allow drug makers to distrib...

latest-news-card-1
Medical Devices

Panel to Review Next-Gen Cancer Detector Test

FDA's announces a 9/23 advisory committee meeting to vote on a Grail PMA for the Galleri test and its use in the early detection of multiple cancers.

Human Drugs

Primus Resubmits Generic Impoyz Petition

Primus petitions FDA to address substantive issues about generic forms of its Impoyz psoriasis drug that were first raised by Encore Dermatology when ...

latest-news-card-1
Human Drugs

FDA Cites Emcure Pharmaceuticals' India Pant Over GMP Issues

FDA cites Emcure Pharmaceuticals' sterile injectable manufacturing facility in Ahmedabad, India, for multiple GMP deficiencies following an inspection...