Approvals
Without holding a meeting of its vaccines advisory committee, the U.S. Food and Drug Administration (FDA) authorized a fourth booster shot for everyone 50 years of age and older.
Antares Pharma has announced that the U.S. Food and Drug Administration has granted approval to its therapeutic Tlando intended for testosterone replacement therapy (TRT).
The FDA released materials for review ahead of Wednesday’s meeting and it appears to paint a picture of insufficient data for approval, noting it is “not exceptionally persuasive.”
The FDA amended its EUA for GlaxoSmithKline and Vir Biotechnology’s sotrovimab for COVID-19. The amendment relates specifically to the BA.2 Omicron sub-variant.
Biogen and Ionis Pharmaceuticals announced that their Phase I study of BIIB078 (IONIS-C9Rx) intended for ALS did not meet clinical endpoints, so they will discontinue the program.
UCB’s oral drug for seizures related to Lennox-Gastaut syndrome is now approved in the U.S. for patients ages two years and older.
The FDA has a very busy week ending the month of March and moving into April, highlighted by a big AdCom vote on Amylyx’s ALS candidate AMX0035 on March 30.
Novavax announced today that its protein-based Covid-19 vaccine, NVX-CoV2373, is included in two new clinical trials that will evaluate the vaccine as a potential Covid booster.
The FDA delayed Bristol Myers Squibb’s (BMS) target date for Reblozyl, approved the company’s melanoma drug and Japan accepted BMS’ NDA for Breyanzi.
Pfizer has announced it received Breakthrough Therapy Designation from the FDA for its vaccine candidate intended to prevent infections caused by the respiratory syncytial virus (RSV).
PRESS RELEASES