As Peptide Rulemaking Stalls, FDA Enforcement Moves Forward

FDA this week cleared three new treatments: Lilly's Olumiant for adolescent alopecia areata, AbbVie's Juvmo for Parkinson's disease, and Mirum and Incyte's Atebrioz for the rare bone disorder FOP.

Compounding pharmacies that set their own safety and accreditation standards now stand the best chance of keeping patient access intact before heavier regulation does it for them.

FDA approves Merck and Eisai's Welireg-Lenvima combination for advanced kidney cancer, a platform-deal roundup covers Novo Nordisk, Genentech, and Roche's tie-ups with Nanexa, Earendil Labs, and Atavistik Bio, and Ron Lanton examines the fight to regulate pharmacy benefit managers.

FDA has approved Welireg plus Lenvima for previously treated advanced clear cell renal cell carcinoma.

InnoCare Pharma and Eli Lilly ink a multibillion-dollar research collaboration, FDA approves Lilly's once-weekly insulin Onswik for type 2 diabetes, and Jen Lamppa talks fixing clinical trial patient enrollment with real-world data.

FDA approves Onswik, Eli Lilly's once-weekly basal insulin for adults with type 2 diabetes.

Chairs of Europe's largest drugmakers urge the EU to boost health spending, speed up clinical trials, and strengthen IP protections before falling further behind the US and China.

FDA approves Ultragenyx's Fayuvi as the first treatment for Sanfilippo syndrome type A, Lisata Therapeutics acquires Marea Therapeutics as mAbxience partners with Sandoz on a hemophilia A biosimilar, and Joe Cunningham argues that executive drug-pricing deals alone won't fix costs.