FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ONCOLOGIC DRUGS ADVISORY COMMITTEE; NOTICE OF MEETING; ESTABLISHMENT OF A PUBLIC DOCKET; REQUEST FOR COMMENTS-SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION 761309/S-001, FOR COLUMVI (GLOFITAMAB) INJECTION; SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION 761145/S-029, FOR DARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE) INJECTION; NEW DRUG APPLICATION 215793, FOR (MITOMYCIN) INTRAVESICAL SOLUTION; SUPPLEMENTAL NEW DRUG APPLICATION 211651/S-013, FOR TALZENNA (TALAZOPARIB) CAPSULES

WASHINGTON, May 8 -- Food and Drug Administration has issued a notice called: Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental Biologics License Application 761309/S-001, for COLUMVI (glofitamab) Injection; Supplemental Biologics License Application 761145/S-029, for DARZALEX FASPRO (daratumumab and hyaluronidase) Injection; New Drug Application 215793, for (mitomycin) Intravesical Solution; Supplemental New Drug Application 211651/S-013, for TALZENNA (talazoparib) Capsules.

The notice was published in the Federal Register on May 8 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (F...