News

The FDA uses real-world data to show how Boostrix prevents infections in infants. The agency also approves a label expansion for Oxlumo, a new administration method for Trogarzo, and accepts an sBLA for Takhzyro. In COVID-19 news, Eiger won’t submit EUA for COVID-19 treatment. Additionally, an OIG reports finds many accelerated approvals have delayed confirmatory trials.

The FDA has approved several new therapies this week, including Amylyx’s oral treatment for ALS, a fourth Avastin biosimilar, a new glaucoma treatment and another indication for Duxipent. The agency also accepted an NDA for therapy for rare immunodeficiency disease.

Jennifer Watts, M.D., M.P.H., chief emergency management medical officer, director of global health and a pediatric emergency medicine physician at Children’s Mercy Kansas City, a children’s hospital in Kansas City, Missouri is one of the 10 up-and-coming healthcare leaders featured in the annual Managed Healthcare Executive feature.

Lissy Hu, M.D., MBA, president of Connected Networks at WellSky, a care coordination network headquartered in Boston, is one of the 10 up-and-coming healthcare leaders featured in the annual Managed Healthcare Executive feature.

Cesar Herrera, MBA, M.P.H., chief executive officer and co-founder of Yuvo Health, a technology-enabled administrative and managed-care solution for federally qualified health centers based in New York City, is one of the 10 up-and-coming healthcare leaders featured in the annual Managed Healthcare Executive feature.

The FDA approved a tumor agnostic treatment for cancer, a lower dose MRI contrast agent, the first generic of Tazorac gel, and a gene therapy for a rare disease. Advisory committees vote down poziotinib for NSCLC and Pepaxto for multiple myeloma and give positive vote for microbiotic-based C. diff therapy. The agency has accepted sNDA for Tukysa for HER2 positive colorectal cancer.