Sacituzumab govitecan's (Trodelvy) accelerated approval in urothelial cancer will be voluntarily withdrawn, Gilead Sciences ...
On Friday, Gilead Sciences, Inc. (NASDAQ:GILD) announced plans to voluntarily withdraw the U.S. accelerated approval for ...
The antibody drug conjugate didn’t help patients live longer in a confirmatory trial, prompting a review of its conditional ...
The NDA has been accepted for UGN-102 for intravesical solution for low-grade intermediate-risk non-muscle invasive bladder cancer.
Gilead is withdrawing the accelerated approval for its blockbuster antibody-drug conjugate Trodelvy for bladder cancer after ...
Gilead Sciences said on Friday it was voluntarily withdrawing its drug, Trodelvy, for patients with a type of bladder cancer ...
The move is a blow to Gilead’s cancer portfolio. Trodelvy, an antibody-drug conjugate granted accelerated approval for ...
Trodelvy’s next big readout is EVOKE-03, which is testing the Gilead drug with Merck’s PD-1 inhibitor Keytruda in PD-L1-high ...
Gilead in 2021 won the FDA accelerated nod for Trodelvy in metastatic urothelial cancer, but continued approval was contingent on the outcome of a confirmatory study. The company in late May said that ...
Astellas Pharma Ltd. today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization for PADCEVâ„¢ (enfortumab vedotin, an antibody-drug conjugate [ADC]) in ...
With its lead candidate in a phase 3 trial for a rare eye cancer, Aura Biosciences is looking to expand the drug into a more ...