Roche announces FDA Priority Review for giredestrant, the first oral SERD showing positive phase III results in the curative, adjuvant setting for ER-positive early breast cancer.
AstraZeneca has announced a three-month extension to the FDA’s review period for camizestrant, a promising treatment for HR+/HER2- advanced breast cancer with ESR1 mutations.
Novo Nordisk has officially filed for FDA approval of a higher, 7.2 mg dose of the weight-loss drug Wegovy®. Submitted under the expedited CNPV program, the new dose promises an accelerated review timeline. Phase 3 trial results indicate the 7.2 mg injection could offer significantly greater weight loss potential than the current standard dose.
