Cullgen will have the option during the initial stages of clinical development to participate equally in the costs, profits and losses
Columvi is part of Roche's industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin lymphoma, which also includes the recently approved Lunsumio to treat follicular lymphoma
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
Collaboration to accelerate and de-risk clinical development of Nanopharmaceutics CNS 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
The new API plant is set up to meet all domestic and international regulatory standards and will manufacture niche molecules that have a global requirement
The judicial response to industry lawsuits on drug pricing regulations have been mixed in the past
Injectafer is now the first and only intravenous (IV) iron replacement therapy indicated for adult patients with heart failure who have iron deficiency
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