Drug Approval | March 06, 2022
USFDA approves expanded use of Bristol Myers Opdivo
The approval marks the first-and-only immunotherapy-based treatment for use before surgery for non-small cell lung cancer
The approval marks the first-and-only immunotherapy-based treatment for use before surgery for non-small cell lung cancer
Positive results reinforce the improved efficacy seen with Opdivo-based treatments in four Phase 3 clinical trials in earlier-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma
The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg
The acquisition complements and strengthens Merck’s cardiovascular pipeline
The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy
Revlimid is a blood cancer drug with sales of US $ 12.1 billion in 2020
The first quarter performance reflects growth across all its business divisions as the company continued to operate at normal levels
Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell certain generic lenalidomide capsules
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