Denise Myshko

Articles by Denise Myshko

The FDA has approved Talvey, a new therapy for treating multiple myeloma patients. The agency has also issued a complete response letter for avasopasem for severe oral mucositis and set a PDUFA date for a monthly MS drug.

FDA Approves new indications for two cancer drugs: Lonsurf combination for metastatic colorectal cancer and Jemperli as frontline treatment for advanced endometrial cancer. The agency has also rejected the BLA for therapy to treat rare skin cancer.

FDA approvals this week include the second nonprescription naloxone nasal spray for opioid overdose, the first drug for a skin infection from pox virus and a drug to treat an eye infection caused by mites. In addition, the FDA has accepted a supplemental application for Ofev in children with rare lung disease.

The FDA has cleared several new products this week, including the first monoclonal antibody for RSV in infants, a novel therapy for newly diagnosed patients with AML and a postexposure anthrax vaccine. Additionally, an FDA decision on donanemab for Alzheimer’s is expected by the end of this year.

Approvals this week include Opill, the first nonprescription oral contraceptive, the use of Veklury for COVID-19 in patients with severe renal impairment, and the earlier use of Leqvio for in heart disease. In addition, Takeda pulled its application for a dengue vaccine.