FDA Approvals - FDA Grants Fast Track Designation to Emergent BioSolutions' BioThrax(R) for
FDA Grants Fast Track Designation to Emergent BioSolutions' BioThrax(R) for Post-Exposure Prophylaxis Against Anthrax ... (RedNova)
Emergent BioSolutions Inc. (NYSE: EBS) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for BioThrax (Anthrax Vaccine Adsorbed) as a post-exposure prophylaxis against anthrax infection.
Advancis Pharmaceutical Announces FDA Decision That its Amoxicillin PULSYS NDA is Not Complete (FinanzNachrichten)
GERMANTOWN, Md., Feb. 13 /PRNewswire-FirstCall/ -- Advancis Pharmaceutical Corporation ( Nachrichten ), a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that it has received a "refusal to file" letter from the U.S. Food and Drug Administration (FDA) for the Company's once-daily Amoxicillin PULSYS New Drug Application (NDA), ...