The U.S. Food and Drug Administration agreed to place Regeneron Pharmaceuticals Inc.’s Biologics License Application (BLA) for the Covid-19 drug REGEN-COV under priority review with a target action date of April 13, 2022.

The U.S. Food and Drug Administration approved Seqirus’ Flucelvax Quadrivalent (Influenza Vaccine), the company’s cell-based quadrivalent influenza vaccine, for an expanded age indication for children as young as 6 months old.

A panel of expert advisers to the U.S. Food and Drug Administration unanimously voted on Oct. 14 to recommend booster shots of Moderna Inc.’s Covid-19 vaccine for Americans aged 65 and older and those at high risk of severe illness or occupational exposure to the virus.

A unit of Abbott Laboratories is recalling two Covid-19 laboratory test kits as they can potentially issue false positive results, the U.S. Food and Drug Administration said on Oct. 14.

Scientists at the U.S. Food and Drug Administration said on Oct. 12 that Moderna Inc. had not met all of the regulatory agency’s criteria to support use of booster doses of the company’s Covid-19 vaccine, possibly because the efficacy of the shot’s first two doses has remained strong.

Pfizer BioNTech

According to a Wall Street Journal report, the preferred Covid-19 shot globally is the Pfizer-BioNTech vaccine.

Merck has submitted data to the U.S. Food and Drug Administration for Emergency Use Authorization (EUA) for the company’s antiviral pill molnupiravir.

The U.S. Food and Drug Administration awarded Roche’s Alzheimer’s disease drug candidate Breakthrough Therapy Designation, bringing the IgG1 antibody gantenerumab closer to finally receiving full FDA approval. 

Acting U.S. Food and Drug Administration Commissioner Janet Woodcock’s days as interim head of the regulatory agency are numbered due to federal regulations. Not only does President Biden have to appoint a new FDA commissioner, he will also need to tap a new head of the National Institutes of Health (NIH) following the retirement announcement of longtime director Francis S. Collins, M.D., Ph.D.

Allogene Therapeutics is halting the clinical trial for the company’s AlloCAR T cancer therapy after finding some chromosomal abnormality in a patient.