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Results For "U.S"

1563 News Found

Helix and QIAGEN to jointly develop and commercialize companion diagnostics for hereditary diseases
Clinical Trials | January 06, 2023

Helix and QIAGEN to jointly develop and commercialize companion diagnostics for hereditary diseases

Partnership to leverage the Helix Laboratory Platform and QIAGEN's biopharma relationships, NGS capabilities, and global regulatory expertise


Provention Bio appoints Rita Jain to Board of Directors
People | January 06, 2023

Provention Bio appoints Rita Jain to Board of Directors

Dr. Jain is a biotechnology industry veteran with more than two decades of experience in pharmaceutical development across her time with ChemoCentryx, AbbVie, Abbott Laboratories, and G.D. Searle and Co


PharmaEssentia sets up a new R&D facility in the Boston Area
News | January 05, 2023

PharmaEssentia sets up a new R&D facility in the Boston Area

The PharmaEssentia Innovation Research Center (PIRC) will advance the company’s diverse pipeline and research footprint in the U.S., driving job creation


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


InnoCare get approval of Tafasitamab with Lenalidomide for the treatment of refractory diffuse large B-Cell lymphoma in Hong Kong
Drug Approval | December 31, 2022

InnoCare get approval of Tafasitamab with Lenalidomide for the treatment of refractory diffuse large B-Cell lymphoma in Hong Kong

Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration and European Medicines Agency


USFDA grants appeal for Ardelyx's XPHOZAH
Drug Approval | December 31, 2022

USFDA grants appeal for Ardelyx's XPHOZAH

Upon approval, XPHOZAH would be the first and only phosphate absorption inhibitor, offering patients a novel mechanism


USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents
Drug Approval | December 31, 2022

USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents

If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine


MindRank gets USFDA clearance of IND application for MDR-001 for treatment of Type 2 diabetes
Drug Approval | December 27, 2022

MindRank gets USFDA clearance of IND application for MDR-001 for treatment of Type 2 diabetes

MindRank expects to initiate a Phase I safety study in the first quarter of 2023.


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