Five persons are indicted on federal charges of conspiracy to smuggle prescription drugs and money laundering conspiracy.
Federal Register notice: FDA makes available a draft guidance entitled Considerations for the Development of Chimeric Antigen Receptor T Cell Products...
FDA lifts clinical holds on Aprea Therapeutics clinical trials involving eprenetapopt in combination with azacitidine in myeloid malignancy programs.
FDA clears a Niramai Health Analytix 510(k) for its SMILE-100 System, a breast thermography device that is intended to help healthcare professionals r...
Biogen releases data it says demonstrate the long-term value of its Aduhelm as an Alzheimers disease treatment.
Members of the House and Senate say PhRMA provided them with misleading information about the role of drug manufacturers in January drug price increas...
Federal Register notice: FDA announces the fee rates under the over-the-counter monograph drug user fee program for fiscal year 2022.
FDA approves an AbbVie supplemental NDA for Rinvoq (upadacitinib) for treating certain adults with moderately to severely active ulcerative colitis.