Drug Approval | July 11, 2023
NMPA approval for first BCMA CAR-T Therapy paves way for more multiple myeloma cell therapies, says GlobalData
Approval to dramatically change CAR-T therapies landscape
Approval to dramatically change CAR-T therapies landscape
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia
Adding 20,000 liters of installed biologics drug substance manufacturing capacity
The €70 million investment will allow the large-scale manufacturing of high-purity reagents for quality control and testing for biopharma customers, increasing annual output by several thousand tons
This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
Construction will begin this year with the new capacity anticipated by 2025
The successful outcome of this study represents an important milestone in Dr. Reddy's commitment to make highquality biosimilar products more accessible and affordable
Olverembatinib is the first and only third-generation BCR-ABL inhibitor approved in China for the treatment of adult patients with tyrosine kinase inhibitors
These announcements are in line with Croda Pharma’s strategy to “Empower Biologics Delivery” and follows news on investments, earlier this year, to expand Croda Pharma’s global manufacturing capabilities to enable the next generation vaccines and therapeutic drugs.
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