Approvals
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)
Novo Nordisk’s oral-semaglutide for type 2 diabetes snagged approval from the U.S. Food and Drug Administration late Friday, marking it as the first such treatment to be approved in pill form.
Merck had the unusual case of having its checkpoint inhibitor Keytruda (pembrolizumab) approved simultaneously in three countries for advanced endometrial carcinoma.
The U.S. Food and Drug Administration approved Keytruda in combination with Eisai’s Lenvima for the treatment of patients with advanced endometrial carcinoma.
Erleada is an androgen receptor inhibitor approved for non-metastatic castration-resistant prostate cancer.
Nucala is the only targeted biologic to be approved for the condition in the six to 11-year age group in the United States, the company said.
The approval marks the first commercial product for Xeris.
The U.S. Food and Drug Administration (FDA) gave the thumbs-up to Boehringer Ingelheim’s Ofev (nintedanib) for systemic sclerosis-associated interstitial lung disease (SSc-ILD).
PRESS RELEASES