FDA accepts an Ultragenyx Pharmaceutical proposal to submit an NDA for UX007 for treating long-chain fatty acid oxidation disorders based on existing ...
Federal Register notice: FDA reopens for 14 days the comment period on its draft guidance entitled Development of a Shared System Risk Evaluation and ...
FDA commissioner Scott Gottlieb says the agency will replace a 2014 guidance on developing new pain drugs with at least four separate guidances to str...
Accord Healthcare recalls one lot of hydrochlorothiazide tablets USP, 12.5 mg, due to a product labeling mix up.
FDA accepts for review an Evolus BLA resubmission for DWP-450 (prabotulinumtoxinA) for treating glabellar lines, also known as frown lines, in adult p...
FDA accepts for review an Ortho Dermatologics NDA resubmission for Duobrii (halobetasol propionate and tazarotene) lotion, indicated for treating plaq...
FDA launches a complex innovative design pilot program for drug clinical trials.
Washington Legal Foundation senior counsel Cory Andrews says FDA lacks authority to implement an HHS proposal to force drug manufacturers to include a...