Government
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.
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.
House Speaker Nancy Pelosi unveiled her plan to lower the prices on up to 250 prescription drugs covered by government-backed plans such as Medicare.
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.
Law firm urges Zantac users to find out their rights against drug maker who knowingly sold potentially carcinogenic medication
September has been a relatively slow month for the U.S. Food and Drug Administration. However, there are two PDFUA dates remaining, although one of those took an unexpected turn that will delay it until later in the year.
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.
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