HHS Requires Bidders In Competitive Range For Recombinant Anthrax Vaccine (rPA) Contract To Submit Development Plan To ... (Medical News Today)
Emergent BioSolutions Inc. (NYSE:EBS) announced that late on April 15th, HHS requested that each bidder in the competitive range for the rPA contract submit its product development plans to FDA for review in advance of an award. Emergent had already requested and is presently scheduling a meeting with the FDA as part of its pre-award activity.

Vion Pharmaceuticals' New Drug Application For Onrigin(TM)Accepted For Review By The FDA (Medical News Today)
Vion Pharmaceuticals, Inc. (OTC Bulletin Board: VION) announced that the New Drug Application (NDA) for its lead oncology therapeutic Onrigin (laromustine) Injection has been accepted for review by the U.S. Food and Drug Administration (FDA). The Company had previously announced the filing of the NDA with the FDA in February 2009.