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...
FDA accepts for review an Accord BioPharma BLA for HLX02, a proposed trastuzumab (Roches Herceptin) biosimilar for treating certain patients with brea...
FDA issues a draft guidance recommending to applicants and manufacturers drug shortage information to be communicated to FDA to assist it in preventin...
The political newsletter Roll Call says efforts to reauthorize a pandemic preparedness bill are likely to include a debate over greater FDA oversight ...
FDA releases the form FDA-483 with three observations issued following an inspection at the Sugar Land, TX-based QuVa Pharma outsourcing facility.
