FDA issues Pierre Fabre Pharmaceuticals a second Complete Response Letter rejecting its BLA for Atara Biotherapeutics investigational cell therapy for...
FDA cites Aurobindo Pharma USA for multiple failures to comply with federal drug supply chain security requirements, including delays in reporting sto...
FDA grants Alessa Therapeutics a fast track designation for Enolen, an experimental localized prostate cancer therapy.
AVID Medical recalls (Class 1 device correction) certain organ recovery and medical convenience kits.
A new FDA guidance details how drug developers can appropriately use Bayesian statistical methods in clinical trials intended to support approvals.
FDA tells Aquestive Therapeutics that deficiencies have been identified in the companys NDA for Anaphylm that currently preclude labeling and post-mar...
FDA accepts for review a Camurus NDA resubmission for Oclaiz (octreotide), a once-monthly treatment for acromegaly.
A December FDA violation letter targeting a schizophrenia drug advertisement from Bristol Myers Squibbs Karuna Therapeutics unit underscores the agenc...
