Approvals
The only other drug currently approved in the U.S. for HIV PrEP is Gilead’s Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).
Janssen’s Invokana snagged another regulatory approval to reduce the risk of end-stage kidney disease, cardiovascular death and worsening of kidney function in adults with type 2 diabetes and diabetic kidney disease.
The FDA’s latest approval for Darzalex is based on results from the Phase III CASSIOPEIA trial that showed the addition of Darzalex to VTd before and after ASCT resulted in deeper responses in patients with the blood cancer.
AbbVie’s Mayvret won expanded approval from the U.S. Food and Drug Administration to shorten the one-daily treatment duration from 12 to eight weeks in treatment-naïve hepatitis C patients without cirrhosis and with compensated cirrhosis.
Bavarian Nordic A/S announced that the U.S. Food and Drug Administration has approved JYNNEOS™ for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.
US FDA 510(k) clearance paves the way for an innovative orthopedic product that offers the potential to improve bone apposition and, as a consequence, patient outcomes 1-3
Phase 3 TITAN is the first registrational study to achieve statistical significance in dual primary endpoints of overall survival and radiographic progression-free survival in patients with mCSPC regardless of extent of disease
The U.S. Food and Drug Administration cleared Abbott’s blood test to help aid in the diagnosis of heart attacks for men and women hours earlier than standard tests and marks significant progress for detecting heart attacks in women.
The vaccine is the only approved non-replicating smallpox vaccine in the U.S. and the only approved monkeypox vaccine anywhere in the world, the company said.
U.S. FDA Approves Supplemental New Drug Application (sNDA) for ERLEADA® (apalutamide) for the Treatment of Patientsbwith Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
PRESS RELEASES