FDA News

CDC Director Rochelle Walensky officially endorsed Pfizer's COVID-19 vaccine in children aged 5 to 11 years, following recommendation from ACIP.

CDC vaccine advisors will meet Thursday to discuss final approval of booster doses of Moderna and J&J vaccines and mix-and-match approach authorized by FDA.

The Vaccines and Related Biological Products Advisory Committee unanimously recommended the Moderna booster on Thurday, the J&J booster on Friday.

SGLT-2 inhibitors have proven effective in disease modification as well as symptom improvement across HF phenotypes and severity. Get a quick summary of the research.

The FDA issued new guidance today providing short-term sodium reduction targets for food manufactures, chain restaurants, and food service operators.

This week, AstraZeneca submitted a request to the FDA for an emergency use authorization for their long-acting antibody cocktail for prophylaxis of COVID-19.

The daily oral CGRP inhibitor is the only agent in the class developed specifically for prevention vs acute treatment of episodic migraine.

Infectious disease expert and NIH-funded researcher Rodger MacArthur, MD, has questions about the evidence on which the Pfizer booster shot recommendations are based.

The Pfizer-BioNTech booster shot is authorized for use in persons aged ≥65 years, at high risk of severe disease, and who have frequent exposure to the virus increasing risk for severe infection.

The DHE nasal spray delivered pain relief at 2 hours for 66% of patients; 93% of those remained pain-free at 24 hours and 86% at 2 days post-dose.