The Latest Breaking News from FDA

Adagio Therapeutics Inc's (NASDAQ:ADGI) Phase 2/3 trials evaluating 300 mg adintrevimab (ADG20) as pre-and-post-exposure prophylaxis (EVADE) and treatment (STAMP) for COVID-19 have met its primary endpoints. Following the emergence of the omicron variant, a pre-specified exploratory analysis in a subset of the pre-exposure cohort, adintrevimab exhibited a clinically meaningful reduction in cases…

The FDA accepted Receptor Life Sciences’ investigational new drug application for RLS103. RLS103, a dry powder inhaled CBD, which is a first-in-class drug/device combination product for the acute treatment of social anxiety disorder.

According to the Centers for Disease Control and Prevention estimates, the omicron BA.2 variant represents approximately 55% of new COVID-19 cases in the U.S., as signs suggest infections are edging higher again in parts of the Northeast.

The gap between the under-vaccinated and the ultra-vaccinated will continue to grow.

Gainers

Sen. Tim Scott, a rising star in the Republican Party with broad popularity in his home state of South Carolina, is getting showered with drug industry money before facing voters this fall.

WASHINGTON — U.S. regulators cleared second booster doses of COVID-19 vaccine from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE for adults 50 and older, making millions more people eligible for the shots as concern grows about a potential new wave of infections.

By Alejandro Bergad The last two years haven’t been great for the CBD industry. The pandemic cratered in-store sales of CBD. Meanwhile, by choosing not to regulate CBD, the FDA left it in a legal gray area, limiting where it can be sold.

Moderna Inc (NASDAQ: MRNA) shares are trading higher by 4.67% at $181.16 after the company received FDA approval for Emergency Use Authorization for a second booster dose of its COVID-19 vaccine.