FDA
The DEA has reclassified GW Pharmaceutical’s cannabidiol epilepsy treatment Epidiolex as a Schedule V product, which will clear the way for commercialization within the next six weeks.
Shares of Verastem closed out Monday trading on a positive note and continues to climb in the premarket following the greenlight for leukemia drug Copiktra, an inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma.
The U.S. Food and Drug Administration (FDA) has a few target action dates scheduled for this week, including one for Sunday, September 23, which was approved in late August.
The U.S. Food and Drug Administration (FDA) approved Teva Pharmaceutical Industries’ Ajovy (fremanezumab) to prevent migraine on Friday, September 16.
AstraZeneca and its research-and-development arm, MedImmune, announced that the U.S. FDA approved Lumoxiti (moxetumomab pasudotox-tdfk) for adults with relapsed or refractory hairy cell leukemia (HCL) who have had at least two previous systemic therapies, including with a purine nucleoside analog.
Amry today announces that the US Food and Drug Administration (“FDA”) has granted Investigational New Drug (“IND”) clearance for AP101.
Loxo Oncology, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-292
Fibrocell Science, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to FCX-013, the Company’s clinical stage candidate for the treatment of moderate to severe localized scleroderma
Privately-held ITF Pharma snagged regulatory approval for Tiglutik, a liquid formulation of riluzole for the treatment of amyotrophic lateral sclerosis.
The U.S. Food and Drug Administration has had a busy August. In addition to the number of draft guidance documents the agency issued during the month, the FDA has also been busy approving a number of new treatments for a variety of diseases.
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