AVID Medical recalls (Class 1 device correction) certain organ recovery and medical convenience kits.
FDA cites Aurobindo Pharma USA for multiple failures to comply with federal drug supply chain security requirements, including delays in reporting sto...
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 new FDA guidance details how drug developers can appropriately use Bayesian statistical methods in clinical trials intended to support approvals.
FDA grants Alessa Therapeutics a fast track designation for Enolen, an experimental localized prostate cancer therapy.
GSK says its investigational hepatitis B drug bepriovirsen met the primary endpoint in two pivotal Phase 3 trials, with regulatory submissions schedul...
FDA says it cant approve a Vanda sNDA for Hetlioz to treat jet lag disorder in its current form.
