[ Price : $8.95]
CDER issues a MAPP with drug shortage management procedures.[ Price : $8.95]
FDA says it expects to implement in the first quarter of 2015 its eCTD Module 1 update.[ Price : $8.95]
Hyman, Phelps & McNamara asks FDA to require specific labeling statements and risk mitigation activities for any approval of Baxte...[ Price : $8.95]
FDA grants Acadia Pharmaceuticals a breakthrough therapy designation for Nuplazid (pimavanserin) for treating Parkinsons disease p...[ Price : $8.95]
Exelixis says a Phase 3 trial of its Cometriq fails to meet its overall survival endpoint for metastatic castration-resistant pros...[ Price : $8.95]
FDA seeks comments on a recent patient advocacy-drafted guidance on developing drugs for Duchenne muscular dystrophy.[ Price : $8.95]
XBiotech says an unscheduled interim analysis of data from a Phase 3 trial of Xilonix shows a trend for improved survival in advan...[ Price : $8.95]
FDA grants 510(k) clearance for Otoharmonics Levo System for use in temporarily relieving the symptoms of tinnitus.