Replimune Group, Inc. faces FDA setbacks with RP1, raising financial risks and dilution concerns. Click here to find out why ...

For instance, "the backlog of FOIAs ... is enormous," he said. Califf said the FDA has far greater opportunities for improved ...

The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters ...

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view | ...

The FDA issues a complete response letter to JNJ's BLA seeking approval for the subcutaneous formulation of Rybrevant in EGFR-mutated non-small cell lung cancer.

Key Takeaways. The FDA issued a second CRL for rivoceranib and camrelizumab, with undisclosed reasons for non-approval. The combination therapy showed improved overall survival and progression ...

Despite an initial PDUFA date of August 22, 2024, the CRL for linvoseltamab was anticipated based on Regeneron’s Q2 earnings call at the beginning of August. 3 “The FDA has not informed us of ...