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Results For "regulatory-approval"

316 News Found

Newly patented bone marrow biopsy device to bolster bone cancer treatment in India, says GlobalData
News | April 10, 2023

Newly patented bone marrow biopsy device to bolster bone cancer treatment in India, says GlobalData

It provides doctors with three indicators: identification of the bone, confirmation of device insertion into the bone, and notification in case of perforation through the opposite end of the bone


MPP signs sublicences with Aurobindo, Cipla and Viatris to produce generic versions of HIV prevention medicine
News | March 30, 2023

MPP signs sublicences with Aurobindo, Cipla and Viatris to produce generic versions of HIV prevention medicine

Licences should enable potentially millions of people living in areas most impacted by HIV to access this innovative prevention medicine through low-cost generic manufacturers


Pfizer acquires Seagen for US$ 43 billion to battle cancer
News | March 14, 2023

Pfizer acquires Seagen for US$ 43 billion to battle cancer

Proposed combination enhances Pfizer’s position as a leading company in oncology


AstraZeneca expands its portfolio by bringing rare disease therapy for patients in India
News | March 01, 2023

AstraZeneca expands its portfolio by bringing rare disease therapy for patients in India

Receives regulatory approval for its molecule ‘Selumetinib’ in India


Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
Drug Approval | February 25, 2023

Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.


CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer
Drug Approval | January 31, 2023

CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer

CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%


Moderna announces an investigational respiratory syncytial vaccine mRNA-1345
News | January 23, 2023

Moderna announces an investigational respiratory syncytial vaccine mRNA-1345

mRNA-1345 demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults


Chindex Medical acquires 10 ViewRay MRIdian Systems for advanced cancer treatment
News | January 06, 2023

Chindex Medical acquires 10 ViewRay MRIdian Systems for advanced cancer treatment

Purchase agreement with ViewRay will make state-of-the art precision radiation therapy available in China


Hester to develop low pathogenic avian influenza inactivated vaccine for poultry
News | December 29, 2022

Hester to develop low pathogenic avian influenza inactivated vaccine for poultry

The company has plans to launch this Vaccine by the end of 2023 after completing the required field studies and obtaining regulatory approvals