The U.S. Food and Drug Administration approved BioXcel Therapeutics Inc.’s IGALMI (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
The U.S. Food and Drug Administration approved Marlborough, Massachusetts-based Sunovion Pharmaceuticals’ Kynmobi (apomorphine HCl) sublingual film for Parkinson’s disease.
FDA Action Alert: Blueprint, Bristol Myers Squibb, Clovis and SunovionBlockbusters, BRCA mutation, Clinical Trial Endpoints, FDA, FDA/Regulatory, Gastrointestinal Stromal Tumors, Metastatic Castration-Resistant Prostate Cancer (mCRPC), New Drug Applications, Non-Small Cell Lung Cancer (NSCLC), OFF Episodes, Parkinson's Disease, PDUFA, Sublingual film, Supplemental Biologics License Application, Supplemental New Drug Application (sNDA), Therapeutics
Despite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here is a look at what is on the schedule for the next two weeks.
Shares of Aquestive Therapeutics were up more than 18 percent following approval from the U.S. Food and Drug Administration for Exservan, a treatment for amyotrophic lateral sclerosis (ALS).
The U.S. Food and Drug Administration rejected Sunovion Pharmaceuticals’ experimental treatment apomorphine sublingual film (APL-130277) for OFF episodes of Parkinson’s disease.