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FDA extends to 2/28/22 the PDUFA action date for a Janssen BLA for its cilta-cel multiple myeloma treatment.[ Price : $8.95]
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]
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FDA approves Novartis Scemblix for two distinct chronic myeloid leukemia indications.[ Price : $8.95]
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Amylyx Pharmaceuticals files an NDA for AMX0035 (sodium phenylbutyrate and taurursodiol), indicated for treating amyotrophic later...