Sun Pharma and Moebius Medical gain fast track designation for MM-II for the treatment of…
MM-II is a novel non-opioid product that uses a proprietary suspension of large, empty, multilamellar liposomes which are intended…
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Browsing Tag
Fast Track designation
US FDA grants fast track designation to Pfizer’s ervogastat/clesacostat combination to treat NASH
FDA’s decision is informed by the results of Pfizer’s non-clinical studies and a phase-IIa clinical study of…
Biogen gets US FDA accelerated approval for Aduhelm to treat Alzheimer’s
It is the first new treatment approved for Alzheimer's since 2003 and is the first therapy that targets the fundamental…
USFDA grants Zydus fast track designation for Saroglitazar to treat primary biliary cholangitis
Zydus announced that the United States Food and Drug Administration (USFDA) has granted ‘Fast Track Designation’ to Saroglitazar…
Xeris Pharma gets US FDA fast track designation for diazepam non-aqueous injection to treat acute…
It was previously granted orphan designations both for the treatment of acute repetitive seizures and for the treatment of Dravet…