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A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as ...
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. Fast track designation must be requested by the drug company.
Last week, the New England Journal of Medicine published a letter from directors at the Food and Drug Administration clarifying some of the intricacies of its new breakthrough designation for ...
Breakthrough Therapy Designation is intended to expedite the development and review of therapeutic candidates that are under investigation for the treatment of serious or life-threatening conditions. Breakthrough Therapy Designation requires preliminary clinical evidence suggesting a candidate may provide substantial improvement over available ...
The FDA's breakthrough tag is given to certain medical devices that provide treatment or diagnosis of life-threatening conditions. The experimental device, known as Blindsight, "will enable even ...
The designation provides additional opportunities to engage the FDA and to support the drug development program through Fast Track designation features. Data from the clinical development program that supported the designation were published in the New England Journal of Medicine and presented as a late-breaking presentation at the 61st ...
The U.S. FDA's Breakthrough Device Designation will speed this innovative technology into the U.S. market. I look forward to more interaction with the ground-breaking team at inbiome," said Professor Carl Wittwer. "We are honored to receive this designation from the FDA," said Dries Budding, CEO of inbiome.