FDA
FDA
12/06/2019
Three applications for the first generic capsules have been granted by the US Food and Drug Administration.
12/06/2019
FDA
FDA
12/06/2019
Three applications for the first generic capsules have been granted by the US Food and Drug Administration.
12/06/2019
FDA
FDA
11/22/2019
This approval comes after the drug was found to be safe and effective in 2 randomized, double-blind, placebo-controlled trials including 655 adults with partial-onset seizures.
11/22/2019
FDA
FDA
11/22/2019
This approval comes after the drug was found to be safe and effective in 2 randomized, double-blind, placebo-controlled trials including 655 adults with partial-onset seizures.
11/22/2019
FDA
FDA
11/22/2019
This approval comes after the drug was found to be safe and effective in 2 randomized, double-blind, placebo-controlled trials including 655 adults with partial-onset seizures.
11/22/2019
FDA
FDA
11/18/2019
In a unanimous vote, the US FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended the approval of a new indication for a triglyceride-lowering drug.
11/18/2019
Urology
Urology
11/15/2019
The new antibacterial drug was approved after it was proven safe and effective in a study of 448 patients with complicated UTIs.
11/15/2019
Urology
Urology
11/15/2019
The new antibacterial drug was approved after it was proven safe and effective in a study of 448 patients with complicated UTIs.
11/15/2019
Urology
Urology
11/15/2019
The new antibacterial drug was approved after it was proven safe and effective in a study of 448 patients with complicated UTIs.
11/15/2019
Screening
Screening
11/07/2019
After performance data showed 95% sensitivity and specificity, the FDA authorized the assay’s marketing in the United States for detection of HIV-1 drug-resistant mutations.
11/07/2019