Approvals
ViiV Healthcare announced that the FDA approved Apretude, a long-acting injectable pre-exposure prophylactic option to reduce the risk of sexually acquired HIV-1.
Going through the most newsworthy stories of the year, BioSpace found trends more than one big story, topics that just kept rising again and again. Here’s a look.
Shares of Coherus BioSciences are climbing in premarket trading after the company announced the FDA greenlit the company’s Humira biosimilar Yusimry.
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.
PRESS RELEASES