As Peptide Rulemaking Stalls, FDA Enforcement Moves Forward

FDA has approved Merck KGaA’s Pimjetmi, an oral CSF-1R inhibitor, for adults with symptomatic tenosynovial giant cell tumors.

FDA approves Bayer’s asundexian as the first Factor XIa inhibitor for secondary stroke prevention, the FDA requires a new safety label warning across all GLP-1 receptor agonists for a potential NAION risk, and AstraZeneca acquires Omniose to add a bioconjugation platform to its vaccine pipeline.

AstraZeneca acquires Omniose, to bolster it's preclinical infectious disease programs.

FDA is requiring manufacturers of all GLP-1 receptor agonists to add a warning for a potential increased risk of NAION.

FDA approves Bayer’s asundexian (Sunharbo), the first Factor XIa inhibitor, for secondary stroke prevention.

argenx acquires Unnatural Products, adding a macrocyclic peptide discovery platform to complement its antibody engineering.

Hims & Hers partners with Eli Lilly to sell Zepbound and Foundayo directly on its platform, Novo Nordisk terminates its research collaboration with Korro Bio, and the FDA grants accelerated approval to Johnson & Johnson’s Rybrevant Faspro in head and neck cancer.

The termination ends a cardiometabolic RNA-editing partnership that was paused for 12 months, closing out a deal under which Korro earned no milestone payments.