FDA Related News

FDA General

OMHHE Marks 10th Anniversary

FDA associate commissioner for minority health Richardae Araojo reviews progress made in the last years by the Office of Minority Health and Health Eq...

Human Drugs

Mallinckrodt NDA Hepatorenal Syndrome Type 1

FDA accepts for review a Mallinckrodt NDA for terlipressin, indicated for treating hepatorenal syndrome type 1.

Human Drugs

FDA OKs Trodelvy for Triple-negative Breast Cancer

FDA approves an Immunomedics BLA for Trodelvy (sacituzumab govitecan-hziy) for treating adult patients with triple-negative metastatic breast cancer.

Medical Devices

CDRH Posts Ventilator EUA Template

FDA posts a ventilator interactive review template for use by those seeking an emergency use authorization.

Human Drugs

Comments on FDA Revised Immunotoxic Potential Guidance

Three stakeholders suggest changes to an FDA revised draft guidance on nonclinical safety evaluation of drugs and biologics immunotoxicity potential....

Comments on FDA Bridging Draft Guidance

Three stakeholders give general and specific comments on an FDA draft bridging guidance for combination products.

Federal Register

Former Commissioner Donald Kennedy Dead at 88

Former FDA commissioner Donald Kennedy (1977-1979) dies due to Covid-19 at the age of 88.

Human Drugs

Biogen Alzheimers BLA Filing Delayed

Biogen says it is delaying a BLA for aducanumab, a potential treatment for Alzheimers disease that it is developing in collaboration with Eisai Co.

FDA General

Hahn Briefs House Committee on Covid-19 Efforts

FDA commissioner Stephen Hahn provides a teleconference briefing to House Energy and Commerce Committee members on the agencys response to the coronav...

Medical Devices

FDA Likely Regretting Unapproved Antibody Test Policy

FDA struggles with policy fallout after allowing dozens of Covid-10 serology (antibody) tests to come onto the market without its normal vetting or re...