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Last updated about 17 hours ago

Activities Report of the Generic Drug Program (FY 2025) – FDARA Title VIII Sections 807 and 805

about 18 hours ago

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the...

Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805

about 18 hours ago

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the...

Patient-Focused Drug Development Glossary

about 18 hours ago

This glossary defines terms that will be used in the series of...

Oncology (Cancer)/Hematologic Malignancies Approval Notifications

about 19 hours ago

FDA does not issue approval announcements for every approval or drug label...

FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma

about 19 hours ago

On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli...

Premium Health Management Inc. dba Premium Health - 721474 - 02/20/2026

about 19 hours ago

Failure to Register and List/Misbranded

Safety Labeling Change Orders

about 23 hours ago

Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)...

FDA to Address Unused Opioids in American Homes

about 24 hours ago

The U.S. Food and Drug Administration today issued a Request for Information...

FDA approves drug for pediatric patients with most common form of dwarfism

1 day ago

FDA approves drug for pediatric patients with most common form of dwarfism

GDUFA Type II API DMF Payment Receipts Report

1 day ago

GDUFA Type II API DMF Payment Receipts Report

Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop - 06/08/2026

1 day ago

This workshop provides an overview of the status of science and research...

Endothelin Receptor Antagonist REMS Information

1 day ago

FDA has determined that a REMS is no longer necessary to ensure...