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The ongoing developments in the approval outcomes and breakthroughs of specialized therapies by the U.S. Food and Drug Administration, including resubmissions leading to approvals and the introduction of new treatments for specific medical conditions.
The U.S. Food and Drug Administration on Wednesday granted expedited approval to daraxonrasib, a daily pill from Revolution Medicines that will be sold under the brand name Rasonque for the most common form of pancreatic cancer. The first-of-a-kind drug blocks a mutated protein that fuels tumor growth in more than 90% of pancreatic cancer cases, an approach that previously eluded drugmakers for decades.
Replimune Group said Thursday that the U.S. Food and Drug Administration approved Tudriqev, its therapy for advanced melanoma, after two previous rejections. The accelerated approval makes Tudriqev the second FDA-approved option for melanoma patients who have stopped responding to immunotherapy drugs, after Iovance Biotherapeutics' Amtagvi.
The U.S. Food and Drug Administration on Wednesday approved Orzeyful (oveporexton), the first drug to treat the full range of narcolepsy type 1 symptoms in adults. The agency granted the approval to Takeda Pharmaceuticals America.