Stealth BioTherapeutics says it has acceded to Barth syndrome patient community requests and submitted an NDA for elamipretide despite FDA concerns th...
Researchers evaluate 10 possible reforms to the FDA accelerated approval pathway.
FDA publishes a draft guidance on a pharmacokinetic approach to alternative dosing regimens for PD-1 and PD-L1 drugs.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.