Tag Archive for: FDA approvals

August kicked off with two FDA approvals—for Merck’s Ebola vaccine in kids and Taiho’s combination therapy for metastatic colorectal cancer—and another rejection for Mesoblast’s aGVHD treatment.

As we move into 2023, BioSpace takes a pause to reflect on the year gone by and some of the most remarkable news bits, looking at the top five noteworthy FDA drug and biologic therapy approvals in 2022.  

The U.S. Food and Drug Administration’s calendar for PDUFA dates is relatively quiet for the middle of July, although it picks up heading into August. Here’s a look at target action dates for the next two weeks.  

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research, adding that the approval fulfills a significant unmet need for patients with severe alopecia areata.