With SpringWorks approval, FDA on track for third-most NMEs since '85

2023 approvals already exceed all but three years in past four decades

November 28, 2023 12:47 AM UTC

Monday’s approval of Ogsiveo from SpringWorks brings FDA’s total number of new molecular entity approvals year-to-date to 52, more than in all but three years since the agency started publishing statistics.

The approval of Ogsiveo nirogacestat, a small molecule γ-secretase inhibitor from SpringWorks Therapeutics Inc. (NASDAQ:SWTX), marks a pair of firsts: the first drug approval for patients with desmoid tumors, a rare type of non-cancerous tumors, and the first approval for the biotech, which spun out of Pfizer Inc. (NYSE:PFE) in 2017...