The U.S. reached 500,000 deaths from COVID-19 on Monday. Since the first person died from the virus in California a little over a year ago, there have been more than 28 million cases. (Reuters)

The Food and Drug Administration says that COVID-19 vaccines targeting new variants may be approved without clinical trials. The guidance, released Monday, aims to speed up development of modified vaccines against the variants. (CNBC Weekly)

Amgen announced it will submit an sNDA for a new indication for Otezla. The drug showed efficacy in its Phase III trial for the treatment of mild to moderate plaque psoriasis. (Endpoints News)

Brainstorm Therapeutics’ cell therapy for amyotrophic lateral sclerosis, NurOwn, doesn’t have enough evidence for FDA submission. The FDA recommended the company not seek approval for the therapy, though Brainstorm may still choose to do so. (STAT)

Dr. Anthony Fauci says mask-wearing may continue into 2022 and that a return to “normality” may be closer by the end of this year. He added, however, that any number of variables could alter that timeline. (The Washington Post)