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FDA issues a draft guidance recommending to applicants and manufacturers drug shortage information to be communicated to FDA to assist it in preventin...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.
CDER director Patrizia Cavazzoni tells the Alliance for a Stronger FDA that the Center is in growth mode after the user fee reauthorization on 9/30/20...
FDA approves a Synapse Biomedical PMA for the NeuRx Diaphragm Pacing System for use in patients with spinal cord injuries who rely on mechanical venti...
FDA outlines research into potential pharmacodynamic biomarkers for biosimilar development.
