Approvals

FDA
Nexlizet is expected to be on the market in the U.S. in July 2020.
FDA
Seqirus snagged approval for Fluad Quadrivalent, the first-and-only quadrivalent adjuvanted influenza vaccine developed to help protect adults 65 years and older against seasonal influenza.
FDA
H. Lundbeck A/S is making a statement with its newly approved treatment for migraine, the first intravenous medication approved for the preventative treatment of migraine.
FDA
The company is planning for its drug for cholesterol lowering medications to hit the streets by the end of March. It will provide a new option to all the patients.
FDA
The approval marks the first once-per-day 24-hour, intravenous COX-2 preferential NSAID, the company said.
FDA
Here’s a look at the two drugs that had dates this week but were approved early and are now on the market.
FDA
The U.S. Food and Drug Administration has a busy week planned for drug review. Here’s a look at this week’s schedule.
FDA
A number of new medications stand a shot at early regulatory approval thanks to the U.S. Food and Drug Administration’s priority review program.
FDA
The FDA gave tentative approval for the drug in 2018, but the holdup was over patent issues.
FDA
Audenz is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic.
PRESS RELEASES