FDA approves a Harmony Biosciences NDA for Wakix (pitolisant) for treating excessive daytime sleepiness in adult patients with narcolepsy.
The Medical Device Innovation Consortium, of which FDA is a part, says it is soliciting public comments on a white paper on best practices for communi...
FDA grants accelerated approval for Genentechs Rozlytrek (entrectinib) for treating cancers in patients having the specific genetic defect NTRK gene f...
FDA issues a guidance to help drug sponsors design nonclinical bone studies to support approval of drugs and biologics intended to treat osteoporosis.
FDA says it is working in several ways with manufacturers to try to mitigate the current shortage of immune globulin products.
FDA says Pfizer has recalled two lots of its migraine drug Relpax because they may not meet the company microbiological specification for the potentia...
FDA grants V-Wave a breakthrough device designation for its interatrial shunt for heart failure.
FDA describes updates it will make to the inactive ingredient database as required under GDUFA 2.