An FDA final guidance delays the enforcement of certain Drug Supply Chain Security Act requirements.
Federal Register notice: FDA announces that it intends to conduct a fit-for-use pilot program to test the processing and analysis of nonclinical study...
FDA approves Avioqs VioOne HIV Profile Supplemental Assay, an enzyme-linked immunosorbent assay for confirmation and differentiation of individual ant...
FDA approves a Gilead Sciences NDA for Veklury (remdesivir), indicated for treating patients with Covid-19 that requires hospitalization.
FDA grants Cala Health a breakthrough device designation for its Cala Trio targeted therapy for treating action tremors in the hands of adults with Pa...
FDA approves a Leo Pharma supplemental NDA for updated prescribing information for Enstilar (calcipotriene and betamethasone dipropionate) Foam to inc...
FDA posts the second quarter 2020 list of potential signals of serious risks or new safety information for drugs identified through the FDA Adverse Ev...
University researchers say delays in FDA new drug regulatory reviews lead to fewer new drugs being in development.