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.
Federal Register notice: FDA determines that 28 drug products listed in the notice were not withdrawn from sale for safety or effectiveness reasons.
FDA issues a complete response letter for Zosano Pharmas Qtrypta 505(b)(2) NDA.
Federal Register notice: FDA makes available a draft guidance entitled Annual Status Report Information and Other Submissions for Postmarketing Requir...
Eli Lilly says it has retained an outside consultant to conduct a comprehensive independent review of systems at its Branchburg, NJ site, following tw...
FDA grants fast track designation for TG Therapeutics ublituximab and umbralisib to treat chronic lymphocytic leukemia.