FDA accepts for review a Supernus Pharmaceuticals supplemental NDA for Qelbree (viloxazine extended-release capsules) for treating attention-deficit h...
FDA clears a Molekule 510(k) for its existing air purifier, Air Pro, classifying it as a Class 2 medical device for medical use for the destruction of...
FDA posts a Federal Register notice of its intent to not approve an Intarcia NDA for a diabetes drug/device combination product.
Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Fa...
Federal Register notice: FDA seeks comments on an information collection revision entitled Drug Supply Chain Security Act Implementation.
FDA clears an Omeza 510(k) for its Omeza Collagen Matrix for chronic wound care.
Former FDA associate chief counsel for litigation James Fraser joins Greenberg Traurig.
Moderna submits trial data to FDA for an evaluation of its Covid vaccine booster shot.