Bristol-Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a strong focus on oncology, immunology, cardiology, and fibrotic diseases, the company utilizes advanced science and research to create life-changing therapies. Bristol-Myers Squibb emphasizes collaboration and partnerships with healthcare professionals, researchers, and patients to enhance treatment outcomes and improve quality of life. The company is committed to addressing unmet medical needs through its comprehensive portfolio of prescription medications and is actively engaged in ongoing research to advance healthcare solutions. Read More
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The FDA has approved Opdivo plus Yervoy for the first-line treatment of MSI-H/dMMR colorectal cancer, supported by the Phase 3 CheckMate-8HW trial results.
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Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).1 This approval is based on the CheckMate-8HW trial, which is the largest Phase 3 trial (n=839) of immunotherapy in patients with MSI-H/dMMR mCRC, evaluating Opdivo plus Yervoy (n=354) vs. Opdivo monotherapy (n=353) in the all-lines setting and Opdivo plus Yervoy (n=202) vs. investigator’s choice chemotherapy (n=101) (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) in the first-line setting.1 Opdivo plus Yervoy met the dual primary endpoints of progression free survival (PFS) when compared to Opdivo monotherapy across all lines of therapy and when compared to chemotherapy in the first-line setting, as assessed by Blinded Independent Central Review (BICR).1 This approval, granted more than two months ahead of the June 23, 2025 Prescription Drug User Fee Act goal date, follows the FDA’s prior decision to grant the application Breakthrough Therapy Designation and Priority Review status.
Bristol-Myers Squibb Co. traces its corporate beginnings back to 1887. Today, the company is a leader in developing innovative drugs like Eliquis for stroke prevention and Opdivo for cancer immunotherapy.
As volatility rattles tech giants, investors are rotating into value stocks for stability and upside. Discover why this five-letter word could be the key to winning in 2025.
Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of a new Opdivo® (nivolumab) formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). Nivolumab for subcutaneous use co-formulated with recombinant human hyaluronidase (rHuPH20), is indicated across multiple previously approved adult solid tumors as monotherapy, monotherapy maintenance following completion of nivolumab plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. The CHMP opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines in the European Union (EU).
As volatility rattles tech giants, investors are rotating into value stocks for stability and upside. Discover why this five-letter word could be the key to winning in 2025.
