FDA sends ViiV Healthcare a complete response letter on its NDA for cabotegravir and rilpivirine, a long-acting regimen for treating HIV-1 infection.
FDA approves a Novo Nordisk NDA for Fiasp (insulin aspart injection) 100 u/mL as a mealtime insulin option for children with diabetes.
FDA issues Sun Pharmaceutical Industries an eight-observation Form 483 after a December inspection at its Gujarat, India drug manufacturing facility.
Federal Register notice: FDA seeks comments on an information collection extension for its Advisory Committee Membership Nominations.
Incyte says its pivotal Phase 3 GRAVITAS-301 study evaluating itacitinib in combination with corticosteroids in certain patients with acute graft-vers...
FDA Review posts the Federal Register notices for the week ending 1/3/2020.
Washington Legal Foundation calls on the HHS Inspector General to reverse its proposal to exclude drug and medical device manufacturers from proposed ...
Federal Register notice: FDA seeks comments on an information collection extension for its guidance on Special Protocol Assessment.