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FDA warns CellEra about multiple repeat Quality System violations in its as a specification developer and distributor of sterile w...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Sarepta Therapeutics Vyondy...[ Price : $8.95]
Federal Register notice: FDA determines for patent restoration purposes the regulatory review period for Biogens Spinraza (nusiner...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Daiichi Sankyos Enhertu.[ Price : $8.95]
FDA approves Novartis Scemblix for two distinct chronic myeloid leukemia indications.[ Price : $8.95]
FDA grants breakthrough device designation to Renew Biosciences Cerezen device to treat mild cognitive impairment associated with ...[ Price : $8.95]
Amylyx Pharmaceuticals files an NDA for AMX0035 (sodium phenylbutyrate and taurursodiol), indicated for treating amyotrophic later...[ Price : $8.95]
FDA accepts for review an Incyte NDA seeking approval of parsaclisib for treating patients with relapsed or refractory follicular ...