Approvals
On Monday, Intra-Cellular Therapies announced that the FDA has approved CAPLYTA to treat the deep depressive episodes of patients with bipolar I or II.
VYVGART is the first-and-only neonatal Fc receptor (FcRn) blocker to be approved by the FDA.
On December 28, the U.S. Food and Drug Administration reported there had been 50 novel drug approvals for the year, and that was just for new chemical entities.
Shares of Global Blood Therapeutics were up more than 10% in late-afternoon trading following regulatory approval of a supplemental New Drug Application for oral Oxbryta (voxelotor) tablets for the treatment of pediatric sickle cell disease.
Although the U.S. FDA largely cleared its calendar ahead of the holidays, it still has a couple open PDUFA dates leading up to January 1, 2022. Here’s a look.
It is also a milestone for the immunoglobulin A nephropathy (IgAN) community, as TARPEYO becomes the first and only FDA-approved treatment to reduce proteinuria in this condition.
The FDA said Orencia is the first drug approved as prophylaxis for aGVHD prevention that included real-world evidence as one component of clinical efficacy.
The FDA approved the latest indication for Rinvoq (upadacitinib) based on data from two Phase III studies, SELECT-PsA 1 and SELECT-PsA 2.
The latest warning letter asks Medtronic to update its systems and procedures in order to deliver safe and high-quality devices to consumers.
The FDA’s approval of Xeljanz is based on Pfizer’s Phase III multicenter, double-blind, placebo-controlled study. Here are more details about the study.
PRESS RELEASES