FDA has approved PD-L1 IHC 22C3 pharmDx, Code SK006m as the only FDA-approved companion diagnostic indicated to aid in identifying first-line patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, whose tumors express PD-L1 and who may be eligible for treatment with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy.
In the latest episode of Vinay Prasad’s extraordinary adventures at FDA, the agency (i.e. Dr. Prasad himself) has issued a Refusal-to-File letter to an mRNA-based influenza vaccine application.
