FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Federal Register

Regulatory Review Periods for Erleada and Xospata

Federal Register notice: FDA determines for patent term extension purposes the regulatory review periods for two drug products Janssens Erleada and A...

latest-news-card-1
Federal Register

Panel to Discuss Next Seasons Flu Shot

Federal Register notice: FDA announces a 3/7 Vaccines and Related Biological Products Advisory Committee meeting to discuss the flu vaccines strain se...

latest-news-card-1
Human Drugs

Senate Judiciary Committee Clears 5 Drug Bills

The Senate Judiciary Committee clears five drug-related bills that would prohibit brand manufacturers from blocking/delaying generic drug competition,...

latest-news-card-1
Human Drugs

GSKs Jemperli Gets OK for Endometrial Cancer

FDA grants full approval to GSKs Jemperli (dostarlimab-gxly) for certain adult patients with mismatch repair deficient (dMMR) recurrent or advanced en...

latest-news-card-1
Federal Register

Tahsildar Debarred for 2 Years Over Canadian Drugs

Federal Register notice: FDA issues an order debarring Hassan Tahsildar for two years from providing services to a person that has an approved or pend...

latest-news-card-1
Biologics

CBER in a Transition Year: Marks

CBER director Peter Marks says the Center is recruiting 125 new staff to work on cell and gene therapies during a transitional 2023.

latest-news-card-1
Medical Devices

EUA for BD Combination Covid-Flu-RSV Test

FDA grants an emergency use authorization for a BD molecular test that differentiates between Covid-19, the flu, and RSV.

latest-news-card-1
Human Drugs

FDA Unsure of Unprecedented Jemperli Trial Plans

FDA medical reviewers raise concerns about GlaxoSmithKlines proposed trials of Jemperli to support a future BLA accelerated approval for some rectal c...

latest-news-card-1
Medical Devices

Industry VMSR Improvement Suggestions

Two medical device associations suggest ways to improve an FDA draft guidance on the Voluntary Malfunction Summary Reporting program created under MDU...

latest-news-card-1
Human Drugs

CDER Researches Convolutional Neural Networks

CDER describes a research study using flow microscopy and convolutional neural networks to monitor changes in product quality attributes.