Crinetics Pharmaceuticals gained FDA approval for Palsonify, the first oral first-line therapy for acromegaly, positioned to compete with established injectable treatments from Novartis and Ipsen. Meanwhile, a federal appeals court upheld the FDA’s lawful approval of generic Entresto, Novartis's blockbuster heart drug, clearing the way for increased generic competition. These developments signify evolving regulatory dynamics in rare disease and cardiovascular therapeutics.