Merck & Co., Inc.’s supplemental Biologics License Application for use of Gardasil in women aged 27 through 45 has been accepted by the FDA and designated for priority review.
WHITEHOUSE STATION, New Jersey-Merck & Co., Inc.’s supplemental Biologics License Application for use of Gardasil in women aged 27 through 45 has been accepted by the FDA and designated for priority review. Gardasil [human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant] is currently indicated for girls and women age 9 through 26 for the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV types 6, 11, 16, and 18.
FDA Approves Encorafenib/Cetuximab Plus mFOLFOX6 for Advanced BRAF V600E+ CRC
December 20th 2024The FDA has granted accelerated approval to encorafenib in combination with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test.