FDA Related News

Medical Devices

Curio Postpartum Depression Device Cleared

FDA clears a Curio Digital Therapeutics 510(k) for its MamaLift Plus, a prescription digital therapeutic for treating postpartum depression.

Human Drugs

Zydus Lifesciences Issued Another FDA-483

An FDA inspection at Zydus Lifesciences injectable manufacturing site in Jarod, India results in a 10-observation Form FDA-483, the second received by...

Get Involved with FDA on AI/ML: Attorneys

Three Alston Bird attorneys urge companies regulated by FDA to engage with the agency on issues involving artificial intelligence and machine learning...

Federal Register

23 No-Longer-Marketed NDAs Withdrawn

Federal Register notice: FDA withdraws the approval of 23 NDAs from multiple applicants because they are no longer marketed.

Medical Devices

FDA Launches Home as a Healthcare Hub

FDA launches a collaboration to develop a Home as a Healthcare Hub prototype to help patients, healthcare providers, and industry.

Human Drugs

New Bladder Cancer Therapy Approved

FDA approves an ImmunityBio BLA for Anktiva (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Gurin (BCG) for treating patients with BCG-unre...

Medical Devices

Sail Fusion Sacroiliac Fusion Device Cleared

FDA clears a Sail Fusion 510(k) for its BowTie Sacroiliac Fusion System.

Animal Drugs

Pediatric Brain Tumor Therapy Approved

FDA grants Day One Biopharmaceuticals accelerated approval for Ojemda (tovorafenib), a Type 2 RAF inhibitor for treating patients six months of age an...

Medical Devices

QS, MDR Issues at Royal Philips China Plant

FDA warns Royal Philips about Quality System and Medical Device Reporting violations at its medical device manufacturing facility in Suzhou, China.

Federal Register

Annual Report on Postmarketing Requirements

Federal Register notice: FDA makes available its annual report entitled Report on the Performance of Drug and Biologics Firms in Conducting Postmarket...