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FDA accepts a Sandoz BLA (351(k) pathway) for a proposed biosimilar to Amgens Enbrel (etanercept), indicated for treating a range ...[ Price : $8.95]
FDA grants Merck accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lun...[ Price : $8.95]
Philadelphia cardiothoracic surgeon Hooman Norchashm meets with CDRH director Jeffrey Shuren and calls for his resignation over hi...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on a consulting firms assessment of the Prescription Drug User Fee Act Workload Adjust...[ Price : $8.95]
Federal Register Notice: FDA reopens the comment period on in vitro methods used to assess bioequivalence of nonsystemically absor...[ Price : $8.95]
Federal Register Notice: FDA releases a draft ICH guidance: M4E(R2): The CTD Efficacy.[ Price : $8.95]
Amicus Therapeutics delays its plans to submit an NDA by the end of the year for migalastat, indicated for treating Fabry disease,...[ Price : $8.95]
FDA grants RegenxBio an orphan drug designation for RGX-111 for treating mucopolysaccharidosis Type 1.