Regulatory
Nexlizet is expected to be on the market in the U.S. in July 2020.
Kiadis Pharma N.V. announced the launch of a first-in-human clinical trial in patients with relapsed/refractory acute myeloid leukemia with off-the-shelf Natural Killer cells manufactured using Kiadis’ FC21 mbIL21 feeder cells and proprietary universal donor platform.
The agency has identified approximately 20 drugs whose active ingredients or finished products are solely sourced in China.
The FDA is reviewing the sNDA under the Real-Time Oncology Review (RTOR) pilot program, which could speed up the process for potential approval.
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.
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.
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.
The target action date is August 21, 2020.
The approval marks the first once-per-day 24-hour, intravenous COX-2 preferential NSAID, the company said.
Here’s a look at the two drugs that had dates this week but were approved early and are now on the market.
PRESS RELEASES