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...
An FDA drug safety alert warns that cases of a rare and serious infection of the genital area have been reported with sodium-glucose cotransporter-2 i...
FDA releases an 8/24 Zimmer Biomet Warning Letter that the company disclosed last week.