Genmab and Pfizer’s TIVDAK sBLA secures full FDA approval
This approval marks a significant milestone as TIVDAK becomes the first antibody-drug conjugate (ADC) with proven overall survival data to receive such endorsement in this patient group. The
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Replimune Group’s biologics licence application (BLA) concerning the RP1 therapy in combination with nivolumab for advanced melanoma.
This partnership follows the US Food and Drug Administration’s approval of ADSTILADRIN in December 2022 for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC)