FDA grants Obsidian Therapeutics a fast track designation for OBX-115, a T cell immunotherapy in combination with a pharmacologically regulatable memb...
Checkpoint Therapeutics says it has completed the resubmission of a BLA for its cosibelimab cancer treatment.
FDA approves Samsung Bioepis Pyzchiva as an interchangeable biosimilar for Janssens Stelara.
FDA approves a Genentech Vabysmo prefilled syringe to treat three retinal disorders with the same medicine as Vabysmo vials.
Venable attorney Robert Schwartz says an updated FDA guidance with alternatives to switching studies for demonstrating biosimilar interchangeability i...
FDA warns Indias Sun Pharmaceutical Industries about repeat CGMP violations at one drug manufacturing facility and in other company facilities.
Attorneys in several law firms analyze the opportunities and risks for FDA-regulated companies arising from the Supreme Court decision to overturn Che...
FDA warns the ozempen.com Web site to stop offering unapproved and misbranded drugs to U.S. consumers.
