Hutchmed completes rolling submission of NDA to USFDA for fruquintinib
NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China
NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China
Cooperative agreement with U.S. Government to advance U.S. biopharma industry and ensure pandemic preparedness
Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure
Gabapentin Tablets are indicated for management of postherpetic neuralgia in adults
Licences should enable potentially millions of people living in areas most impacted by HIV to access this innovative prevention medicine through low-cost generic manufacturers
The award recognizes and supports promising female scientists working in mass spectrometry
The San Francisco facility is part of Thermo Fisher’s global pharma services network of more than 15 locations supporting cell and gene therapies.
Valbenazine Capsules (RLD Ingrezza) had estimated annual sales of USD 1,235 million in the U.S. (IQVIA MAT December 2022).
The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide
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