After delaying a review action last month, FDA now approves a KalVista Pharmaceuticals NDA for Ekterly (sebetralstat) for treating acute attacks of he...
FDA accepts for priority review a Denali Therapeutics BLA for tividenofusp alfa for treating Hunter syndrome.
A ProPublica investigative report says FDA inspectors continue to have issues arising from the dismissal of many of their support staff.
A new FDA report examines the demographic representation of clinical trials supporting the approval of 50 novel drug therapies last year.
FDA removes risk evaluation and mitigation strategies requirements for all currently approved CAR T cell therapies, saying the programs have burdened ...
UCB reports positive data from a Phase 3 clinical trial evaluating fenfluramine as an adjunctive treatment for rare epileptic encephalopathy condition...
An appeals court rules for FDA that a clinically superior drug is not the same as a drug that is otherwise the same.
Achieve Life Sciences files an NDA for cytisinicline for treating nicotine dependence as part of smoking cessation in adults.
