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FDA accepts for review two applications from Sunovion for expanded indications for its schizophrenia drug Latuda.[ Price : $8.95]
Titan Pharmaceuticals files a 505(b)(2) NDA for Probuphine (buprenorphine hydrochloride), indicated for treating opioid dependence...[ Price : $8.95]
Warner Chilcott petitions FDA asking it to tighten bioequivalence criteria for ANDA sponsors seeking approval for generic copies o...[ Price : $8.95]
FDA classifies as Class 1 a recall involving Hospiras Symbiq One- and Two-Channel Infuser touchscreen drug pumps.[ Price : $8.95]
A new report from Rep. Edward Markey (D-MA) calls for more FDA oversight authority over pharmacy compounding.[ Price : $8.95]
FDA grants priority review to Bayer HealthCare for its NDA for Stivarga (regorafenib) tablets, indicated to treat patients with me...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on the PHS guideline on infectious disease issues in xen...[ Price : $8.95]
CDRH posts a transcript of a workshop held 8/30 on Post Approval Studies: Design, Methodology, and Role in Evidence Appraisal Thro...