Medtronic recalls its Xomed NIM Contact Reinforced Electromyogram (EMG) Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tubes due t...
FDA releases the FDA-483 citing 13 observations that were at the center of an Alvotech-received complete response letter on its biosimilar BLA for a c...
FDA warns Texas Longhorn RXs Talon Pharmacy of Boerne, Boerne Texas, about selling adulterated compounded drug products.
FDA grants $2 million to Marker Therapeutics to support the treatment arm in a Phase 2 trial of its T-cell candidate to treat patients with acute myel...
The Alliance for Pharmacy Compounding calls on FDA to reject recommendations in a National Academies report and instead maintain patient access to com...
Federal Register notice: FDA makes available a draft guidance entitled Computer Software Assurance for Production and Quality System Software.
FDA publishes a final rule setting a new deadline for the annual summary report required under the Right to Try Law.
The International Society for Cell & Gene Therapy says a federal court decision that FDA cannot regulate cell therapy products as drugs is flawed.
