FDA Related News

Federal Register

Colon Cancer Blood Test Goes to Panel

Federal Register notice: An FDA advisory committee schedules a 5/23 meeting to review a Guardant Health PMA for its Shield blood test for colorectal c...

Human Drugs

PMRs and PMCs Generally on Schedule: FDA Report

FDA says most applicants completed or released most of the premarketing requirements or commitments reported in the agencys FY 2022 annual report.

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23 No-Longer-Marketed NDAs Withdrawn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

Exactech Recalls Equinoxe Shoulder Devices

Exactech recalls its Equinoxe Shoulder System devices packaged in defective bags from facilities unused inventory.

Medical Devices

FDA Warns on OTC Anti-choking Devices

FDA warns against the use of over-the-counter anti-choking devices because they are not approved or cleared by the agency.