FDA News

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.

With the post-LER PAD indication, rivaroxaban becomes the only anticoagulant in 2 decades to demonstrate safety and efficacy in the high-risk population.

The Pfizer-BioNTech COVID-19 vaccine is the first to receive full approval from the FDA.

The novel prandial insulin formulation from Eli Lilly is now approved for administration via continuous subcutaneous insulin infusion with an insulin pump.

The new indication for empagliflozin is to reduce risk of CV death and hospitalization for heart failure in patients with HFrEF,

In a new joint statement, the HHS officially recommends booster shots of mRNA COVID-19 vaccines and outlines plan to start rollout this fall.

Update: The FDA authorized a 3rd COVID-19 vaccine dose for the immunocompromised to combat emergence of more pathogenic SARS-CoV-2 strains.

The approval represents the first new treatment for generalized systemic lupus erythematosus in over a decade.