FDA approves an ImmunityBio BLA for Anktiva (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Gurin (BCG) for treating patients with BCG-unre...
FDA clears a Sail Fusion 510(k) for its BowTie Sacroiliac Fusion System.
FDA grants Day One Biopharmaceuticals accelerated approval for Ojemda (tovorafenib), a Type 2 RAF inhibitor for treating patients six months of age an...
Exactech recalls its Equinoxe Shoulder System devices packaged in defective bags from facilities unused inventory.
FDA warns against the use of over-the-counter anti-choking devices because they are not approved or cleared by the agency.
FDA clears a Royal Philips 510(k) for its Philips Zenition 30 mobile C-arm imaging device.
FDA announces that its Medical Devices Advisory Committees Molecular and Clinical Genetics Panel is scheduled to review a Guardant Health PMA for its ...
FDA issues Abeona Therapeutics a complete response letter on a BLA for prademagene zamikeracel (pz-cel), requesting additional information to satisfy ...
