FDA Webview
X
about-us-banner

FDA Related News

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

World Cancer Day Treatment Virtual Discussion

FDA and EMA schedule a 2/1 virtual public discussion on innovative therapies for some cancers to mark World Cancer Day.

latest-news-card-1
Human Drugs

Defender Pharma Complete Response on Nausea Drug

FDA sends Defender Pharmaceuticals a complete response letter on its NDA for intranasal scopolamine (DPI-386) for preventing nausea and vomiting induc...

latest-news-card-1
Medical Devices

Musk Reports Implanting 1st Chip in Human Brain

Neuralink founder Elon Musk announces the first chip implant in the brain of a human clinical trial participant.

latest-news-card-1
Federal Register

Panel to Discuss Geron Imetelstat NDA

Federal Register notice: FDA announces a 3/14 Oncologic Drugs Advisory Committee meeting to discuss a Geron NDA for imetelstat for injection.

latest-news-card-1
Federal Register

Guide on Genome Editing Gene Therapies

Federal Register notice: FDA makes available a final guidance entitled Human Gene Therapy Products Incorporating Human Genome Editing.

latest-news-card-1
Federal Register

Guide on CAR T Cell Product Development

Federal Register notice: FDA makes available a final guidance entitled Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Pr...

latest-news-card-1
Federal Register

Draft Guide on Race/Ethnicity Trial Data

Federal Register notice: FDA makes available a draft guidance entitled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies f...

latest-news-card-1
Human Drugs

Hold Lifted on INmune Alzheimers Trial

FDA lifts a 2022-imposed clinical hold against INmune Bios XPro (XPro1595; pegipanermin) and its Alzheimers disease clinical trial.

latest-news-card-1

Feds Looking at Medical Record AI: Bloomberg

Bloomberg Law says the Justice Department is looking into the use of AI in electronic health records to push doctors to prescribe particular treatment...

latest-news-card-1
Biologics

Enhertu sBLA Priority Review for Solid Tumors

FDA accepts for priority review an AstraZeneca and Daiichi Sankyo supplemental BLA for Enhertu (trastuzumab deruxtecan) for treating adult patients wi...