Drug Approval | December 18, 2025
FDA nod to Johnson & Johnson’s AKEEGA for aggressive prostate cancer
Patients with BRCA mutations often face aggressive disease and poor prognosis
Patients with BRCA mutations often face aggressive disease and poor prognosis
Bertozzi currently serves as the Baker Family Director of Sarafan ChEM-H, Anne T. and Robert M. Bass Professor at Stanford University, and Investigator of the Howard Hughes Medical Institute
The company operates a chain of mid-sized multi-speciality hospitals
The approval of Nuzolvence (zoliflodacin) follows a collaborative development effort with the Global Antibiotic Research and Development Partnership
The state-of-the-art facility is a 350-bedded, multi-specialty tertiary care hospital
Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia
More than five drug candidates from his team progressed to human trials including drugs like Rilematovir (Phase IIb), and Bedaquiline
The inspection concluded with one minor observation in Form 483
Glenmark's Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug
The Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA
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