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Results For "clinical-development"

521 News Found

FDA approves Keytruda as adjuvant treatment for non-small cell lung cancer
Drug Approval | January 30, 2023

FDA approves Keytruda as adjuvant treatment for non-small cell lung cancer

Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US


Pharma companies developing vaccines with efficacy against Omicron variants will gain competitive advantage in China, says GlobalData
News | January 27, 2023

Pharma companies developing vaccines with efficacy against Omicron variants will gain competitive advantage in China, says GlobalData

The WHO has urged China to increase adoption of mRNA vaccines, given their high efficacy against variant strains.


SK bioscience appoints new executives
People | January 23, 2023

SK bioscience appoints new executives

Two biopharmaceutical experts join SK bioscience to strengthen the future strategies


US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease
News | January 23, 2023

US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease

The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial


Dr. Reddy’s completes clinical studies of its rituximab biosimilar for filing in the U.S., Europe
Drug Approval | January 21, 2023

Dr. Reddy’s completes clinical studies of its rituximab biosimilar for filing in the U.S., Europe

Following successful completion of full set of clinical studies of proposed rituximab biosimilar candidate DRL_RI, Dr. Reddy’s will now prepare to file in the United States, European Union and other regions


CNS Pharmaceuticals appoints Faith L. Charles as Chair of the Board of Directors
People | January 04, 2023

CNS Pharmaceuticals appoints Faith L. Charles as Chair of the Board of Directors

Over 30 years of deep life sciences industry experience with a wide range of expertise in corporate governance, capital markets, licensing and strategic collaborations


Ablaze and Yonghe Pharma initiate development and manufacturing agreement for targeted radiopharmaceutical therapies
News | December 28, 2022

Ablaze and Yonghe Pharma initiate development and manufacturing agreement for targeted radiopharmaceutical therapies

Yonghe as the CDMO partner will provide production process development and cGMP manufacturing services for Ablaze


Lynparza in combination with Abiraterone and Prednisone approved in the EU as treatment for metastatic castration-resistant prostate cancer
Clinical Trials | December 22, 2022

Lynparza in combination with Abiraterone and Prednisone approved in the EU as treatment for metastatic castration-resistant prostate cancer

First PARP inhibitor and new hormonal agent combination approved for these patients in Europe


Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer
Drug Approval | December 20, 2022

Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer

This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting


Aurigene reports results of AUR101 in phase II study in US patients
News | December 19, 2022

Aurigene reports results of AUR101 in phase II study in US patients

AUR101, with a good ADME/PK profile and high bioavailability, has demonstrated inhibition of IL-17A in whole blood from psoriasis patients