Signal
9 articles covering "FDA approval"
The FDA approved Celcuity's gedatolisib for PIK3CA wild-type HR+/HER2- advanced breast cancer after it more than tripled progression-free survival over fulvestrant alone in the Phase 3 VIKTORIA-1 trial.
The FDA cleared a subcutaneous starting dose for Eisai and Biogen's Leqembi Iqlik, letting early Alzheimer's patients begin anti-amyloid treatment with a 15-second at-home injection instead of IV infusion.
GSK and Spero's tebipenem pivoxil becomes the first oral carbapenem cleared in the US, four years after an FDA rejection.
Atezolizumab becomes the first therapy cleared for use only in patients whose blood tests reveal molecular residual disease after bladder removal surgery.
AstraZeneca's baxdrostat (Baxfendy) became the first aldosterone synthase inhibitor approved in the US on May 18, 2026, giving the estimated 23 million Americans whose blood pressure remains uncontrolled on two or more drugs a new mechanistic option.
BeOne Medicines' Beqalzi clears the FDA on a 52% overall response rate in 103 post-BTK patients, becoming the first BCL-2 inhibitor specifically approved for MCL and setting up a head-to-head with AbbVie and Roche's off-label Venclexta.
AstraZeneca and Daiichi Sankyo's trastuzumab deruxtecan won simultaneous neoadjuvant and adjuvant approvals on May 15, backed by 927-patient DESTINY-Breast11 and 1,635-patient DESTINY-Breast05 Phase III trials.
The FDA approved Foundayo (orforglipron), a once-daily oral GLP-1 receptor agonist from Eli Lilly, for adults with obesity or overweight. It is the first new molecular entity approved under the National Priority Voucher program and the fastest NME approval since 2002.
FDA approves pembrolizumab for a subset of ovarian cancer patients after Phase 3 KEYNOTE-B96 trial shows the first overall survival benefit ever demonstrated by an immunotherapy in this setting.