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Federal Register notice: FDA identifies four drug substances to be added to its list of bulk drug substances (active pharmaceutica...[ Price : $8.95]
Bristol Myers Squibb and Bluebird Bio re-file their BLA for idecabtagene vicleucel, indicated for treating patients with heavily p...[ Price : $8.95]
Catalyst Pharmaceuticals loses against FDA in a lawsuit over the agency's approval of competitor Jacobus Pharmaceuticals Ruzurgi (...[ Price : $8.95]
FDA grants Ethicon a breakthrough device designation for its transbronchial microwave ablation technology using robotic-assisted b...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage...[ Price : $8.95]
FDA accepts from Merck two supplemental BLAs for Keytruda (pembrolizumab) and its use in triple-negative breast cancer.[ Price : $8.95]
Eton Pharmaceuticals files an NDA for zonisamide oral suspension for treating partial seizures in patients with epilepsy.[ Price : $8.95]
FDA seeks comment on a proposal to add four bulk drug substances to the bulk list for drug compounders.