FDA Updates for the Week of Jan. 23, 2023

January 28, 2023

The FDA approved a new drug for type 2 diabetes and a new BTK inhibitor for rare blood cancer while Keytruda got another indication in lung cancer. But Evusheld lost its EUA for COVID-19. The agency accepted an sNDA for Jardiance for CKD and officials said they plan to hold advisory committee meeting for Biogen’s ALS drug.

One in Four Adults over 70 are Visually Impaired

January 23, 2023

Researchers found that visual impairment is more prevalent among those who are older, Hispanic, non-White, and less educated and have lower incomes.

FDA Updates for the Week of Jan. 16, 2023

January 21, 2023

This week the FDA approved new indications for already available therapies, including Brukinsa for chronic lymphocytic leukemia and an accelerated approval for Tukysa for HER2-positive colorectal cancer, as well as an extended-release form of risperidone for schizophrenia. The agency also issued a complete response letter for Lilly's Alzheimer’s drug and accepted an application for a NASH drug.

FDA Updates for the Week of Jan. 9, 2023

January 14, 2023

The FDA has approved two medications: Rybelsus for first-line treatment of diabetes and asthma rescue combination medication. The agency has accepted an sNDA for Rexulti for Alzheimer’s agitation, and Eisai submits new Alzheimer’s drug for full approval.