Depending on the type of cancer, it can be used as monotherapy or combination as a part of first line regimen, maintenance regimen or relapsed settings
First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations
Acceptance based on results from the phase 3 KEYNOTE-091 trial
No new studies have been requested
Building the future of food in the birthplace of cell-cultured milk
First and only once-weekly patch for convenient, well-tolerated delivery of most used drug for the treatment of Alzheimer's-related dementia
If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.
AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).
The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022
Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years
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