Pink SheetUS Food and Drug Administration leadership affirmed that its goal is to release complete response letters for products that have not yet been approved by the agency, but acknowledged some “legal” obst
In VivoThe US Food and Drug Administration’s complete response letter for Replimune ’s RP1 appears to point the company in a different direction than its previous interactions with the agency, providing fur
Pink SheetThe US Food and Drug Administration’s complete response letter for Replimune ’s RP1 appears to point the company in a different direction than its previous interactions with the agency, providing fur
Pink SheetThe US Food and Drug Administration’s approval decisions for novel agents will come from different divisions in the second half of 2025, compared to the first half, the Pink Sheet ’s US FDA Performan