A total of seven new molecular entities (NME) have been approved by the U.S. FDA this year, while another seven therapies received dreaded complete response letters from the agency. Out of 9 FDA approvals in February, including two BLAs, three NDAs, three supplemental applications, and one abbreviated NDA, were three NME clearances.
Two years ago, BioWorld reported on 30 therapeutics and vaccines in development for COVID-19, about 3,000 people had died from the disease, and societal lockdowns began. Today, therapeutics and vaccines have ballooned to 1,048, deaths are at 6 million, and the world remains on edge due to highly transmissible variants and breakthrough infections. One thing remains the same: Scientists still do not know where the SARS-CoV-2 virus originated.