FDA publishes the last in a series of four guidances on aspects of patient-focused drug development.
The Justice Department charges three former top officials at Magellan Diagnostics over their role in allegedly concealing a device malfunction that pr...
FDA warns Somerset, NJ-based Aspire Pharmaceuticals about multiple violations in its production of dietary supplements and human drugs.
Scorpion Capital says its research into deaths and adverse events associated with Harmony Biosciences narcolepsy drug Wakix indicates FDA should withd...
CDER issues an updated MAPP for Office of Clinical Pharmacology IND review processes.
FDA posts a draft guidance entitled Human User Safety in New and Abbreviated New Animal Drug Applications to inform sponsors of the types of informati...
Abbott issues a safety notice for the Readers and batteries used as part of the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash g...
OncoSec says its Tavo-EP in combination with Mercks Keytruda failed to meet the overall response rate primary endpoint in a Phase 2 trial with some me...
