Drug Approval | February 18, 2022
USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib
The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022
The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022
Phase 2 clinical trial to begin in 2022 with participation by Cedars Sinai Medical Center, University of Utah, and City of Hope
Resolv ER may remedy leading causes of blindness in adults
The supplemental adolescent approval enhances Solosec’s strong position as the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV
Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years
The device will facilitate the treatment of cerebral vasospasm following hemorrhagic stroke
Last year, the company's early-stage breast cancer detection test became the first such test to receive the Breakthrough Device Designation
Parkinson's disease treatment is the first and only carbidopa/levodopa (CD/LD) tablet designed to be divided for precise dosing
Adds five years of market exclusivity on approval
Nearly 1 million people are living with multiple sclerosis in the United States. Spasticity is a commonly reported symptom for MS, with an estimated prevalence of spasticity of 67%
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