FDA approves Celgenes Reblozyl as the first treatment for adults with anemia who have beta thalassemia and require regular red blood cell transfusions...
FDA accepts for review a Cassiopea NDA for clascoterone cream 1% for treating acne.
President Trump says new e-cigarette rules will be out within a week, including raising the purchasing age from 18 to 21.
Teleflex begins a Class 1 recall of its Babi.Plus 12.5 cm H2O Pressure Relief Manifold, which is used with its ventilators, because the devices vented...
Life Spine and two of its executives agree to pay nearly $6 million to resolve kickback allegations in a whistleblower suit.
CDRH regulatory advisor Joshua Silverstein tells a Webinar what changes were made to the final Special 510(k) guidance in response to comments on the ...
AbbVie files a supplemental NDA for Imbruvica (ibrutinib) in combination with rituximab for the first-line treatment of younger patients with chronic ...
Federal Register notice: FDA withdraws approval of a Haemonetics ANDA for Anticoagulant Citrate Dextrose SolutionA, USP, in plastic bags.