Approvals
BrainStorm Cell Therapeutics is making a strong comeback after the FDA was a little impressed with Phase III results of amyotrophic lateral sclerosis treatment.
Shares of Reata Pharmaceuticals have plunged nearly 40% in premarket trading after an FDA advisory panel recommended against the approval of its Alport syndrome disease treatment, bardoxolone.
The regulatory agency just placed new safety warnings on that drug class, which will impact AbbVie’s Rinvoq (upadacitinib), a drug the company has seen as a successor to its revenue-driving Humira.
The approval of Keytruda also now includes stage III melanoma following complete resection for pediatric patients 12 years and up.
The U.S. Food and Drug Administration is wrapping up 2021 with a fairly busy schedule for the month of December. Here’s a look at the first half of the month.
This afternoon, the U.S. Food and Drug Administration expanded the Emergency Use Authorization for Eli Lilly’s monoclonal antibody treatment combination of bamlanivimab and etesevimab.
The approval was based on Phase II data from the PLEIADES study that showed patients treated with the combination therapy generated an overall response rate of 84.8%.
The FDA’s decision is based on positive results from two Phase III trials, the PROTECT and CONSTANT, on the drug’s efficacy.
Sigilon Therapeutics announced it may have discovered the reason why its experimental cell therapy treatment for severe hemophilia A was placed on clinical hold by the FDA.
Results from its GEM-3 trial on VYJUVEK demonstrated statistical significance in its ability to promote complete wound healing within six months compared to a placebo.
PRESS RELEASES