FDA Updates for the Week of Nov. 28, 2022

December 3rd 2022

This week, the FDA made two approvals, the first-ever microbiota product and a second indication for Brexafemme, and issued a CRL for a therapy for brain metastasis from neuroblastoma. The regulatory agency also granted priority review for a Duchenne gene therapy, and accepted three applications: for a cutaneous T-cell lymphoma therapy, for an antibiotic for drug-resistant infections and Evkeeza for children with rare high cholesterol. Additionally, Genentech has withdrawn Tecentriq’s indication for bladder cancer and Aldeyra has submitted an NDA for the novel dry eye therapy reproxalap.

Effects After the Pandemic Caused Teens' Brains to Age

December 2nd 2022

A recent study shows teenager's mental health and brain maturation increased due to effects from the COVID-19 pandemic.

COVID-19 Associated With Decreased Sperm Concentration, Study Finds

December 2nd 2022

Evidence that COVID-19 might affect male fertility is accumulating, although it is an incomplete picture and there is no final word on the subject. This study found a possible effect on concentration but not on sperm motility or morphology.

Study Looks at How an HIV Protein Can Alter Immune Cells and Fuel Chronic Inflammation

December 2nd 2022

The findings of research results published in Cells Reports implicate the Nef protein as a possible cause of disease-causing inflammation that persists even when an HIV infection is controlled.

COVID-19 Pandemic Caused Only a Dip in HIV Prevention, Care Services

December 1st 2022

Results reported by CDC researchers show a sharp drop-off in HIV prevention and care services, such as preexposure prophylaxis prescriptions, in the second quarter of 2020 but then a rebound in third quarter.