FDA Updates for the Week of October 11, 2021

October 16, 2021

In COVID-19 news: An advisory committee recommends both J&J's and Moderna’s booster, Regeneron seeks full approved for its treatment and Merck seeks EUA for treatment. In cancer, the FDA approves Verzenio for early breast cancer, Keytruda for advanced cervical cancer, and Tecentriq in early nonsmall cell lung cancer.

FDA Updates for the Week of Oct. 4, 2021

October 09, 2021

Pfizer officially seeks EUA for pediatric COVID vaccine, AstraZeneca seeks EU for COVID-19 prevention, J&J submits data for COVID-19 booster, a gene therapy is approved for leukemia, and Janssen submits Stelara for psoriatic arthritis in children.

FDA Updates: Genentech Withdraws Tecentriq Indication; New Approvals for Xarelto, Tibsovo

August 28, 2021

Tecentriq loses indication, Xarelto is approved for reduce risks of cardiovascular events, Tibsovo is approved for rare cancer, Skytrofa is a new, once-weekly growth hormone, and supplemental application is filed Orencia graft-versus-host disease.

FDA Updates: Merck’s Pneumococcal Vaccine Leads the Week

July 24, 2021

New vaccine for pneumococcal disease, an sNDA approved based on real-world data, a new therapy for skin and muscle disease, Keytruda combination receives full approval in endometrial cancer, a new diabetes therapy is approved, and another JAK inhibitor misses PDUFA date round out this week’s FDA news.