FDA warns CellEra about multiple repeat Quality System violations in its as a specification developer and distributor of sterile wound dressings.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Sarepta Therapeutics Vyondys 53 (golodirsen).
Federal Register notice: FDA determines for patent restoration purposes the regulatory review period for Biogens Spinraza (nusinersen sodium).
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Daiichi Sankyos Enhertu.
FDA approves Novartis Scemblix for two distinct chronic myeloid leukemia indications.
FDA grants breakthrough device designation to Renew Biosciences Cerezen device to treat mild cognitive impairment associated with Alzheimers disease....
Amylyx Pharmaceuticals files an NDA for AMX0035 (sodium phenylbutyrate and taurursodiol), indicated for treating amyotrophic lateral sclerosis.
FDA accepts for review an Incyte NDA seeking approval of parsaclisib for treating patients with relapsed or refractory follicular lymphoma, marginal z...