[ Price : $8.95]
Vanda asks FDA not to approve any generic Fanapt until expiration of a three-year exclusivity period granted for labeling changes ...[ Price : $8.95]
An International Pharmaceutical Regulators Forum working group solicits comment on principles for extrapolating biosimilar indicat...[ Price : $8.95]
Tonix says its TNX-102 SL failed to reach statistical significance in a Phase 3 fibromyalgia trial and will now move to a Phase 3 ...[ Price : $8.95]
FDA extends the compliance date for UDI label and global database submissions to 9/24/18 for certain Class 1 medical devices.[ Price : $8.95]
Evoke Pharma says it is preparing a 505(b)(2) NDA for Gimoti (metoclopramide), indicated for relieving symptoms associated with ac...[ Price : $8.95]
GlaxoSmithKline and Innoviva release positive data from the pivotal Phase 3 FULFIL study with investigational closed triple combin...[ Price : $8.95]
The Clinical Decision Support Coalition calls on FDA to develop a new form of case study guidance to provide the agency view on a ...[ Price : $8.95]
Aerie Pharmaceuticals files an NDA for Rhopressa (netarsudil ophthalmic solution) 0.02%, a novel once-daily eye drop designed to l...