FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Medical Devices

Baxter Recalls AK 98 Dialysis Machines

Baxter recalls its AK 98 dialysis machines based on recent recalls by other manufacturers related to the potential risk of exposure to hazardous chemi...

latest-news-card-1
Federal Register

Guide on Circulating Tumor DNA Biomarker Trials

Federal Register notice: FDA makes available a final guidance entitled Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development....

latest-news-card-1
Federal Register

Clinical Trial Financial Disclosure Info Collection

Federal Register notice: FDA seeks comments on an information collection extension entitled Financial Disclosure by Clinical Investigators.

latest-news-card-1
Federal Register

Panel Meeting to Discuss Leg Pain BLA

Federal Register notice: FDA announces a 1/10 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss a Seikagaku BLA for radicul...

latest-news-card-1
FDA General

Gottlieb Worried About RFK Jr. Pick for HHS

Former FDA Commissioner Scott Gottlieb predicts a difficult path for Robert F. Kennedy Jr. to win Senate confirmation as HHS secretary due to his extr...

latest-news-card-1
Human Drugs

J&J Seeks Tremfya Approval for Pediatric Uses

Johnson & Johnson files two supplemental BLAs for Tremfya (guselkumab) for treating certain children with moderate-to-severe plaque psoriasis and acti...

latest-news-card-1
Human Drugs

Applied Therapeutics NDA Denied Approval

FDA issues Applied Therapeutics a complete response letter on its NDA for govorestat and its use for treating classic galactosemia.

latest-news-card-1
Medical Devices

FDA OKs Mentor's Larger Breast Implants

FDA approves a Mentor Worldwide PMA for its MemoryGel Enhance Breast Implants for reconstruction breast surgery in post-mastectomy women.

latest-news-card-1
Human Drugs

Circulating Tumor DNA Use Guidance

FDA publishes a guidance to help sponsors planning to use circulating tumor DNA as a biomarker in some cancer trials.

latest-news-card-1
Human Drugs

Patheon Italia FDA-483 Out

FDA releases the form FDA-483 with four observations from a 2023 inspection at the Monza, Italy-based Patheon Italia sterile drug manufacturer.