Dec 16, 2022
Interim guidance for influenza treatment with limited oseltamivir; FDA panel vote on omecamtiv mecarbil; Tecentriq gains new indication; Potential combo COVID-19 and influenza vaccine; Detect COVID-19 tests recalled.
Dec 9, 2022
New authorization for COVID-19 vaccines in certain children; Narcan nasal spray to be reviewed for OTC status; Empagliflozin assessed in children with diabetes; a major depressive disorder therapy gains fast track status; and Tecentriq has an indication withdrawn.
Dec 2, 2022
FDA pull bebtelovimab; compounding guidance issued in light of the amoxicillin shortage; the first fecal microbiota treatment is approved; a treatment for Alzheimer disease agitation shows promise; and a gene therapy for duchenne muscular dystrophy is accepted for Priority Review.
Nov 18, 2022
Newly approved gynecologic cancer treatment; Zejula has it’s use restricted; intrauterine system use extended; a second insulin product is approved as a biosimilar to Lantus; and an FDA Advisory Committee take a vote on tenapanor.
Nov 4, 2022
USPSTF recommendations on estrogen and progesterone; semaglutide assessed in obese teenagers; efficacy and safety data released for maternal RSV vaccine; updates to clozapine REMS; FDA panel vote on investigational CNS/leptomeningeal metastasis treatment.