FDA articulates a flexible regulatory approach to chemistry, manufacturing and controls for cell and gene therapies, a move the agency says is intende...
FDA grants Novita Pharmaceuticals an orphan drug designation for its experimental cancer drug NP-G2-044 for treating pancreatic cancer.
FDA approves a Sentynl Therapeutics NDA for Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients.
FDA grants Alessa Therapeutics a fast track designation for Enolen, an experimental localized prostate cancer therapy.
FDA cites Aurobindo Pharma USA for multiple failures to comply with federal drug supply chain security requirements, including delays in reporting sto...
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...
