OFF Episodes Archives

FDA Gives Thumbs-Up to Sunovion’s Under-the-Tongue Parkinson’s Drug

Approvals, Cells, Complete Response Letter, FDA, FDA/Regulatory, Neurodegenerative Disorders, OFF Episodes, Parkinson's Disease, Sublingual film, The Lancet

The U.S. Food and Drug Administration approved Marlborough, Massachusetts-based Sunovion Pharmaceuticals’ Kynmobi (apomorphine HCl) sublingual film for Parkinson’s disease.

May 22, 2020/by BioSpace

FDA Action Alert: Blueprint, Bristol Myers Squibb, Clovis and Sunovion

Blockbusters, 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.

May 11, 2020/by Andrew Humphreys

Acorda to terminate 25 percent of headcount via restructuring

Business, Clinical Data, Layoffs, Multiple Sclerosis, OFF Episodes, Parkinson's Disease, Restructuring, Seizures, Shares, U.S. Supreme Court

Acorda Therapeutics will terminate approximately 25 percent of headcount as the company initiates a corporate restructuring.

October 24, 2019/by BioSpace

FDA approves new add-on drug for Parkinson’s

Adenosine A2A Receptor Antagonists, Approvals, Carbidopa/Levodopa, FDA, FDA/Regulatory, OFF Episodes, Parkinson's Disease

The U.S. FDA approved Kyowa Kirin’s Nourianz (istradefylline) as an add-on treatment to levodopa/carbidopa in adults with Parkinson’s disease who experience “off” episodes.

August 28, 2019/by BioSpace