Drug Approval | April 12, 2025
FDA approves Opdivo plus Yervoy as treatment metastatic colorectal cancer
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
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Protein-bound Paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas
Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population
He will lead the final stages of work to commission the 54,000-square-foot facility and then lead ongoing operations at the site
Augtyro is the only FDA-approved treatment option for NTRK-positive tumors studied in both TKI-naïve and TKI-pretreated patients across solid tumors
Seymour is recognized as one of the foremost quality leaders in the pharmaceutical industry
Seymour is recognized as one of the foremost quality leaders in the pharmaceutical industry
Late-breaking data to be featured in an oral presentation at the American Association for Cancer Research (AACR) annual meeting on Monday, April 8 and highlighted as part of the official meeting press program
Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial
This is the fourth authorized indication in Europe for Reblozyl, a first-in-class treatment for patients with disease-related anemia
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