FDA accepts for review an Evoke Pharma 505(b)(2) NDA for Gimoti, a nasal spray product candidate for relieving symptoms in adult women with acute and ...
FDA approves Sun Pharmaceutical Industries Cequa (cyclosporine ophthalmic solution) 0.09%, indicated to increase tear production in patients with kera...
Endo resumes its suit challenging FDAs interim policy on drug compounding and seeking removal of vasopressin from Category 1 nominations for bulk comp...
FDA approves Eisai and Mercks kinase inhibitor Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinom...
Two pharmaceutical trade associations suggest changes to a draft antibiotic limited population pathway guidance.
Federal Register notice: FDA issued a priority review voucher to Ultragenyx Pharmaceutical for its approved rare pediatric disease product application...
Federal Register notice: FDA seeks comments on an information collection extension entitled Guidance for Industry on Postmarketing Adverse Event Repor...
Four stakeholders comment to FDA on the agencys draft of a limited population pathway for antibacterial and antifungal drugs.