priority review

Showing 5 posts of 5 posts found.

FDA Priority Review for Pfizer investigational leukaemia drug

February 22, 2017
Research and Development, Sales and Marketing EMA, FDA, Inotuzumab ozogamicin, Pfizer, priority review

Pfizer has announced that its leukaemia treatment inotuzumab ozogamicin has been accepted for Priority Review by the US Food and …


Roche’s Actemra granted Priority Review by FDA

January 24, 2017
Manufacturing and Production, Sales and Marketing Actemra, FDA, Roche, priority review

Roche’s drug, Actemra (also known as RoActemra in Europe), has been granted priority review designation by the FDA for the …

Roche says EMA accepts its marketing applications for Ocrevus to treat multiple sclerosis

June 28, 2016
Manufacturing and Production, Research and Development, Sales and Marketing EMA, Ocrevus, Roche, US FDA, drug development, drug trial, multiple sclerosis, priority review, regulation

Cancer drugmaker Roche (SIX: ROG) said the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for its …

Genentech cancer immunotherapy gets Priority FDA Review in bladder cancer

March 15, 2016
Manufacturing and Production, Research and Development FDA, Genentech, Roche, atezolizumab, bladder cancer, priority review

The US FDA has granted Roche subsidiary Genentech a Priority Review for atezolizumab in treating advanced bladder cancer, whose disease …

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FDA grants Eisai’s Lenvima priority review for kidney cancer

January 19, 2016
Manufacturing and Production Breakthrough Therapy Designation, Eisai, FDA, Kidney cancer, Lenvima, lenvatinib, priority review, renal cell carcinoma

The FDA has accepted Eisai’s supplemental New Drug Application (sNDA) for its anti-cancer agent Lenvima for use in the treatment …

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