FDA denies an Acorda Therapeutics petition that asked the agency to carefully consider the sufficiency of the applicants identification and qualificat...
FDA approves two Teva Pharmaceutical Industries NDAs for AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) and ArmonAir Resp...
FDAs Office of Regulatory Affairs plans to implement its long-awaited Program Alignment Group initiative by 5/15.
Bard Peripheral Vascular recalls its Halo One Thin-Walled Guiding Sheath because the sheath body may separate from the sheath hub while removing the d...
FDA tells Regulus Therapeutics that a 6/2016 clinical hold remains in effect and it requested more information on the development program for RG-101, ...
President Donald Trump signs an executive order requiring FDA and other government agencies to eliminate two existing regulations for every new rule i...
FDA Review posts the Federal Register notices for the week ending 1/27/2017.
FDA employees launch a parody Twitter account called @AltFDA to help keep agency information flowing during a blockade ordered by the Trump Administra...