The increased drug load enabled by the nanoformed particles also allows smaller implants with sustained release properties to be developed.
Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma
Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio
Patent Term Extension is designed to restore some of the patent life lost during the regulatory review process for new drugs.
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
Agreement provides customers in the majority of Europe* access to supply through Univar Solutions distribution network
New facility will strengthen the security of supply for global pharmaceutical and biotech customers and will support the continued development and production of lifesaving clinical and commercial-scale therapeutics for patients worldwide.
Construction will begin this year with the new capacity anticipated by 2025
The collaboration focuses on the development and sharing of Standard Quality and Regulatory Documentation (StaQRD), a standard guide for the electronic transfer of information
Hampton joins PCC from Accord Healthcare, where he was the President and responsible for accelerating the firm's growth strategy
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