FDA Approves LIVTENCITY for the Treatment of Adults and Pediatric Patients with Post-Transplant CMV Infection/Disease That Is Refractory to Treatment with Ganciclovir, Valganciclovir, Cidofovir or Foscarnet
FDA Authorizes Revisions to Fact Sheets for Casirivimab and Imdevimab Monoclonal Antibodies for Treatment of COVID-19 to Include a Change in Dose and Option for Subcutaneous Administration
FDA Authorizes Sotrovimab Monoclonal Antibody for Treatment of COVID-19
FDA Authorizes Tocilizumab Monoclonal Antibody for Treatment of COVID-19
FDA Approves KERENDIA (Finerenone) to Reduce the Risk of Sustained EGFR Decline, End Stage Kidney Disease, Cardiovascular Death, Non-Fatal Myocardial Infarction, and Hospitalization for Heart Failure in Adult Patients with CKD Associated with T2D
FDA Approves TEMBEXA (Brincidofovir) for the Treatment of Human Smallpox Disease in Adult and Pediatric Patients Including Neonates
FDA Approves a New Dosage Regimen for ERBITUX (Cetuximab) based on Model-Informed Drug Development (MIDD)
FDA Approves BREXAFEMME (Ibrexafungerp) for Adult and Post-Menarchal Pediatric Females with Vulvovaginal Candidiasis
FDA Approves TRUSELTIQ for Adults with Locally Advanced or Metastatic Cholangiocarcinoma with a FGFR2 Fusion or Other Rearrangement
FDA Approves RYBREVANT for Adults with NSCLC with EGFR Exon 20 Insertion Mutations
FDA Announces Availability of a Federal Register Notice on Evaluating the Clinical Pharmacology of Peptides
FDA Approves JEMPERLI (Dostarlimab-gxly) for Adult Patients with Mismatch Repair Deficient Recurrent or Advanced Endometrial Cancer
FDA Approves ZYNLONTA For Adults with Large B-Cell Lymphoma
FDA Authorizes Bamlanivimab and Etesevimab Monoclonal Antibodies for Treatment of COVID-19
FDA Approves TEPMETKO (Tepotinib) for Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring MET Exon 14 Skipping Alterations
FDA Approves ORGOVYX (relugolix) for the Treatment of Advanced Prostate Cancer
FDA Approves MARGENZA in Adult Patients with Metastatic HER2-Positive Breast Cancer who Have Received Two or More Prior Anti-HER2 Regimens