FDA grants Oncolytics Biotech a fast track designation for Reolysin, an immuno-oncology viral agent for treating metastatic breast cancer.
FDA clears a Medrobotics 510(k) for the Flex Robotic System and its use for colorectal procedures.
FDA sends TherapeuticsMD a complete response letter on its NDA for TX-004HR, an investigational applicator-free estradiol vaginal softgel capsule for ...
FDA clears a CurveBeam 510(k) for InReach, a cone beam computed tomography imaging system designed for the hand, wrist, elbow and lower extremities in...
U.S. Senators Michael Bennet (D-CO), Orrin Hatch (R-UT), Richard Burr (R-NC), and Bob Casey (D-PA) introduce legislation to improve clinical trials fo...
A new study in the British Medical Journal questions the usefulness of data from post-approval clinical trials required for certain novel drugs approv...
U.S. Senators Roger Wicker (R-MS) and Amy Klobuchar (D-MN) introduce legislation aimed at providing patients and advocates the ability to play a large...
FDA Review posts the Federal Register notices for the week ending 4/28/2017.