Remove p applicant Bristol Myers Squibb
article thumbnail

Opdivo® (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma, Regardless of PD-L1 Expression Status

The Pharma Data

–(BUSINESS WIRE)– Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) (injection for intravenous use), in combination with fluoropyrimidine- and platinum-containing chemotherapy, was approved by the U.S. to 0.90; P =0.0002), as well as in patients with PD-L1 combined positive score (CPS) ?

HR 52
article thumbnail

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) for the.

The Pharma Data

1 This application was approved under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible. to 0.86; P =0.0008). to 0.77; P =0.0005). Cardiovascular, Immunology and Oncology, Bristol Myers Squibb. “UC

Drugs 52
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

China National Medical Products Administration Approves Tislelizumab in Combination with Chemotherapy in First-Line Advanced Squamous Non-Small Cell Lung Cancer

The Pharma Data

We are humbled by the expeditious review of our supplemental new drug application and hope our broad development program for tislelizumab will continue its momentum and benefit additional patients,” said Wendy Yan, Senior Vice President and Global Head of Regulatory Affairs at BeiGene. ii She J, Yang P, Hong Q, et al.

article thumbnail

First-Line Treatment for Patients with Advanced Renal Cell Carcinoma

The Pharma Data

–(BUSINESS WIRE)– Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo ® (nivolumab) in combination with Cabometyx ® (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma (RCC). PRINCETON, N.J.–(BUSINESS months vs. 8.3

HR 52
article thumbnail

BeiGene Announces Inclusion of Three Innovative Oncology Products in China National Reimbursement Drug List (NRDL)

The Pharma Data

A marketing authorization application (MAA) for BRUKINSA for the treatment of patients with WM who have received at least one prior therapy or as first-line treatment for patients unsuitable for chemo-immunotherapy has been accepted by the European Medicines Agency (EMA). i Moreau P, Richardson PG, Cavo M, et al. Carfilzomib.