The first COVID-19 vaccine is fully approved by the FDA, we'll go into all that that entails and also news regarding booster doses, off-label recommendations, promising antibody treatments and a BLA submission from Moderna for their vaccine.

This week we have significant news on the status of a third COVID-19 vaccine booster dose, as well as news for an encephalitis vaccine, another jardiance indication, an FDA warning concerning patient wristbands, and Jemperli gets accelerated approval.

Big news on the COVID-19 vaccine booster dose. The CDC issues new recommendations on vaccines. What protection the Moderna vaccine offers after 6 months. A treatment approved for Pompe disease. And the FDA denies an application for a new roxadustat indication.

The FDA authorizes a postexposure prophylaxis for COVID-19; a new treatment is okay'd for lupus; a higher dose naloxone nasal spray became available; the risk evaluation and mitigation program for Clozapine has had important changes, and finally, Istodax has had an indication withdrawn.

This week we have news of the FDA requesting a change to statin prescribing labels, a new vaccine for streptococcus pneumoniae, a new plaque psoriasis cream, a stem cell therapy gets fast tracked as a possible Parkinson disease treatment, and there's a new treatment approved for Progressive Familial Intrahepatic Cholestasis (PFIC).

This week on the pod we speak about a fact sheet update for the Janssen COVID vaccine. Pfizer and BioNTech are working on a booster version of their vaccine. A supplement is found to contain a prescription ingredient. There's a new treatment for patients with diabetic kidney disease. And two popular sunscreen brands are recalled due to the presence of benzene.

This week Pfizer recalled their smoking cessation therapy Chantix. A treatment for acute bacterial skin and skin structure infections becomes available. Aduhelm, the newly approved Alzheimer Disease treatment, has its label updated. A blood lead level test is recalled, and there's updates to the cancer drug Keytruda.

The FDA grants Emergency Use to Actemra to treat hospitalized COVID patients. Revisions are been made to the fact sheets for the Moderna and Pfizer BioNTech COVID vaccines to include information related to the risk of myocarditis and pericarditis. A new treatment is approved for some cancer patients allergic to E. coli-Derived asparaginase products. Solosec gets an expanded indication and a new drug application for a HIV-1 treatment has been submitted.

This week the FDA approved a first-in-class switch for an antihistamine nasal spray, a new oral contraceptive, and Pradaxa was approved to prevent venous thromboembolism in pediatric patients. Meanwhile, real-world data on the efficacy of the COVID-`9 treatment remdesivir has been published.

This week the FDA approved a regenerative skin tissue therapy and a treatment for advanced mastocytosis, while Novavax's vaccine for COVID and a novel treatment for MDD show promise. Also the FDA issue warning concerning hand sanitizers.