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...
Endos Par Pharmaceutical recalls seven lots of treprostinil injection 20g/20mL due to the potential for the presence of silicone particulates in the p...
Federal Register notice: FDA seeks comments on an information collection extension entitled Data To Support Social and Behavioral Research as Used by ...
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.
