FDA accepts for review Replimune's BLA resubmission that is seeking accelerated approval of RP1 (vusolimogene oderparepvec) in combination with nivolumab for treating advanced melanoma.
In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 6.
FDA accepts for review Replimune's BLA resubmission that is seeking accelerated approval of RP1 (vusolimogene oderparepvec) in combination with nivolumab for treating advanced melanoma.
In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 6.
FDA issues Sobi a Complete Response Letter on its BLA that is seeking approval of NASP (nanoencapsulated sirolimus plus pegadricase) for treating adults with uncontrolled gout.
The European Commission opens a formal antitrust investigation into whether Sanofi abused its dominant market position by allegedly conducting a misleading campaign against a rival influenza vaccine marketed by CSL Seqirus.
