FDAs Oncologic Drugs Advisory Committee votes 10 to 2 that the CodeBreak 200 confirmatory study cannot be reliably interpreted as the basis for Amgens...
AstraZeneca suggests several things FDA could add to a draft guidance on QTc information in drug and biologic labeling.
The Reagan-Udall Foundation publishes a report with strategies for FDA to consider to improve public understanding of FDA and its regulated products.
CDRH director Jeffrey Shuren says FDA believes there is more Philips Respironics needs to do as part of its recall of ventilators and BiPAP and CPAP m...
FDA publishes a draft guidance to assist sponsors in developing drugs and biologics to treat stimulant use disorders.
FDA grants Noxopharm an Orphan Drug Designation for CRO-67, a drug candidate for treating pancreatic cancer.
Medtronic warns healthcare professionals about stolen defective McGRATH MAC video laryngoscopes that have been offered for sale illegally by unauthori...
FDA researchers say they found no difference in safety when patients were switched between interchangeable biosimilars and the reference biologic.
