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172 News Found

CDSCO, NRAI meets WHO international standards for vaccine regulations
Policy | October 14, 2024

CDSCO, NRAI meets WHO international standards for vaccine regulations

India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI


Aurigene Oncology gets positive results of Phase 1 study for CAR-T cell therapy for multiple myeloma
Diagnostic Center | October 09, 2024

Aurigene Oncology gets positive results of Phase 1 study for CAR-T cell therapy for multiple myeloma

India’s first trial for a novel autologous BCMA directed CAR-T cell therapy in patients with relapsed / refractory multiple myeloma


Clariant to launch eight new high-performing excipients at the CPHI Milan 2024
News | October 03, 2024

Clariant to launch eight new high-performing excipients at the CPHI Milan 2024

Clariant is launching high-performing pharmaceutical ingredients to support the evolution of safe and effective medicines


Fermenta Biotech receives EU GMP Certification for its Dahej facility
News | September 23, 2024

Fermenta Biotech receives EU GMP Certification for its Dahej facility

This approval reflects company’s unwavering commitment that the quality assurance


Fasenra recommended for approval in the EU by CHMP for treatment of EGPA
Drug Approval | September 23, 2024

Fasenra recommended for approval in the EU by CHMP for treatment of EGPA

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids


Siegfried opens quality control lab in Minden
News | September 04, 2024

Siegfried opens quality control lab in Minden

The new facility further improves the operational efficiency and readies the site for the completion of the new large-scale production plant


Mastek and Onyx Health partner to accelerate healthcare data interoperability
Digitisation | August 28, 2024

Mastek and Onyx Health partner to accelerate healthcare data interoperability

The partnership will provide health plans with an out-of-the-box compliance solution for CMS-9115 and CMS-0057 rules


BI Sky Global successfully completes FDA MoCRA registration
Drug Approval | August 25, 2024

BI Sky Global successfully completes FDA MoCRA registration

MoCRA mandates that all facilities involved in the manufacturing and processing of cosmetic products for sale in the United States


Balancing wellness and waste: sustainable solutions for medical packaging: MHolland
Packaging | August 22, 2024

Balancing wellness and waste: sustainable solutions for medical packaging: MHolland

Stringent regulatory environments can make OEMs reluctant to change processes and materials for approved medical devices


Sigachi Industries unveils new products PureCoat and UltraMod
News | August 21, 2024

Sigachi Industries unveils new products PureCoat and UltraMod

Sigachi's entry into the coatings market is strategically timed to capitalize on the industry's growth potential