Drug Approval | June 16, 2023
Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam
The company will submit its comprehensive response on these observations to the US FDA
The company will submit its comprehensive response on these observations to the US FDA
Investment enables development of revolutionary multi-omic platform using super-resolution imaging technology for earlier disease detection and accelerated discovery of therapeutics
The new range of HDPE bottles is compliant with US FDA, EU regulations and Chinese DMF registration for use in dry pharmaceutical applications
Total investments could reach €70 million, of which approximately 15% in R&D and 85% in capex, that would be deployed from 2026
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Launched Pathology Laboratory in Vijayawada offering a wide range of best-in-class diagnostic services with over 2500+ tests
Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio
UTD2 is the world's first oral epothilone microtubule inhibitor
Pfizer is likely to show GSK significant competition
Survey of Unmet Needs in chronic myeloid leukemia (CML SUN) data signal need for amplified patient voice during treatment discussions that balance quality of life (QoL), efficacy, and tolerability goals across all lines of therapy
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
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