FDA News and Regulatory Updates

The CDC recommends against the J&J COVID-19 vaccine if Pfizer or Moderna mRNA shots are available while affirming that any COVID vaccine is better than none.

Referencing waning immunity of the 2-dose mRNA series and availability of the vaccine to youth in this age group for more than a year, FDA determined that benefits outweigh risks.

Get a quick look at 12 of the many FDA-approved drugs in 2021 for conditions commonly seen in primary care.

The 13-10 vote was not without controversy as panel members discussed concerns over the novel antiviral's safety risks and modest efficacy.

Booster doses for US adults at least 18 years of age are expected to be available as soon as this weekend.

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.

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.

FDA approval of mezopelumab follows the phase 3 SYNAPSE trial in which the anti-Il-5 monoclonal antibody reduced by 57% the need for nasal polyp surgery.

The first nonsteroidal mineralocorticoid receptor antagonist to be approved for adults with T2D-associated CKD fills a significant treatment void for millions of patients.

From obesity to pneumococcal disease, we have picked the top 6 FDA-approved drugs every primary care physician should know about from the second quarter.