Medical Device and Diagnostic Industry (MD+DI)

FDA Issues First Update to 510(k) Exemption Guidance Since 2019

FDA adds five product codes to its premarket notification exemption list, expanding 510(k) exemptions for certain low-risk ...

FDA advisers to weigh updated COVID vaccine targeting XFG subvariant

The Food and Drug Administration’s (FDA) advisory committee on vaccines this week will consider whether to change the ...

FDA panel to consider Covid shot update

The FDA’s outside vaccine advisers plan to convene Thursday to recommend which Covid-19 strain vaccine manufacturers should target for the 2026-2027 season’s products, all while the country’s vaccine ...
Becker's Hospital Review

FDA panel backs update to fall COVID shot formula

FDA panel backs fall Covid shot update to target the XFG variant, enabling manufacturers to reformulate vaccines for the upcoming surge season.

Smoothie recall update as FDA sets most serious risk level

A Utah-based wholesaler voluntarily recalled a banana smoothie product after it was notified of a potential salmonella risk.

FDA urged to update safety labels on antidepressants

An FDA official told a room of Make America Healthy Again supporters Monday that the agency needs data to make any changes to ...
Regulatory Affairs Professionals Society

This Week at FDA: WH reviewing candidates for FDA commissioner, Diamantas’ rare disease outreach, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
Morningstar

Update on FDA Priority Review of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection as a Starting Dose for Early Alzheimer's Disease

TOKYO and CAMBRIDGE, Mass., May 8, 2026 /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period ...
Healio

FDA updates Tremfya label to include joint damage inhibition in psoriatic arthritis

The FDA has approved a label expansion for the interleukin-23 inhibitor guselkumab to include the inhibition of structural ...
Newsweek

Peanut Recall Update for 19 States As FDA Sets Risk Level

See more of our trusted coverage when you search. Prefer Newsweek on Google to see more of our trusted coverage when you search. Roasted peanut products distributed across 19 states are under recall ...