FDA publishes a draft guidance on a pharmacokinetic approach to alternative dosing regimens for PD-1 and PD-L1 drugs.
FDA alerts health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co. due to quali...
FDA has approved a Bayer sNDA extending to seven years the duration of use for the companys Mirena IUD birth control device.
Johnson & Johnson says it has data supporting the use of its Covid-19 vaccine as a booster shot for people previously vaccinated with its single-shot ...
FDA issues an emergency use authorization for the BD Veritor at-home Covid-19 rapid antigen test that uses a smartphone camera to provide results of a...
FDA warns Australias Natural Beauty of CGMP issues in its production of OTC drugs.
Moderna completes a rolling BLA and requests a priority review for the submission seeking full licensure of its Covid-19 vaccine.
Federal Register notice: FDA sends to OMB an information collection extension entitled Establishment and Operation of Clinical Trial Data Monitoring C...