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FDA grants Vaccinex an orphan drug designation for its therapeutic monoclonal antibody VX15, which is currently being investigated...[ Price : $8.95]
FDA posts a final guidance on Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and...[ Price : $8.95]
FDA accepts for priority review a Clovis Oncology NDA seeking accelerated approval for rucaparib and its use in treating certain a...[ Price : $8.95]
Lilly asks FDA to reject ANDAs for its Forteo and ultimately treat it as a biological product after revising the regulatory defini...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Cape Apothecary, College Pharmacy, Frontida BioPharmm, Huzhou Aupower Sanitary C...[ Price : $8.95]
FDA approves in part and denies in part a Cubist petition asking that specific actions be required of ANDA and 505(b)(2) NDA appli...[ Price : $8.95]
FDA classifies as Class 1 a recall involving Aleres INRatio 2 PT/INR Home Monitoring System for warfarin therapy.[ Price : $8.95]
FDA approves a Pfizer NDA for Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules, indicat...