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Parkinson's Disease News (Page 4)
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FDA Approves Kynmobi (apomorphine hydrochloride) Sublingual Film for the Treatment of Parkinson’s Disease OFF Episodes
MARLBOROUGH, Mass.--(BUSINESS WIRE) May 21, 2020 --Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) has approved Kynmobi (apomorphine HCI)...
FDA Approves Ongentys (opicapone) as an Add-On Treatment for Patients with Parkinson’s Disease Experiencing “Off” Episodes
SAN DIEGO – April 27, 2020 – Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Ongentys (opicapone) 25 mg and 50...
FDA Approves Nourianz (istradefylline) as an Add-On Drug to Treat Off Episodes in Adults with Parkinson’s Disease
TOKYO--(BUSINESS WIRE)-- August 28, 2019 – Kyowa Kirin Co., Ltd., (Kyowa Kirin, TYO: 4151) announces today that the U.S. Food and Drug Administration (FDA) has granted approval for Nourianz...
FDA Medwatch Alert: FDA Review Finds No Increased Risk of Prostate Cancer with Parkinson's Disease Medicines Containing Entacapone (Comtan, Stalevo)
August 13, 2019 – A U.S. Food and Drug Administration (FDA) review of additional data found no increased risk of prostate cancer with the use of entacapone to treat Parkinson’s disease. We conducted ...
FDA Approves Inbrija (levodopa inhalation powder) for Intermittent Treatment of OFF Episodes in People with Parkinson’s Disease
ARDSLEY, N.Y.--(BUSINESS WIRE) December 21, 2018 --Acorda Therapeutics, Inc. today announced that the U.S. Food and Drug Administration approved Inbrija™ for intermittent treatment of OFF episodes in ...
Acadia Pharmaceuticals Announces FDA Approval of New Dosing Formulation and Strength for Nuplazid (pimavanserin)
SAN DIEGO--(BUSINESS WIRE)--Jun. 29, 2018-- Acadia Pharmaceuticals Inc. today announced FDA approval of a new capsule dose formulation and a new tablet strength of Nuplazid (pimavanserin) to help in...
FDA Approves Osmolex ER (amantadine) for the treatment of Parkinson’s Disease and Drug-Induced Extrapyramidal Reactions
BRIDGEWATER, N.J., Feb. 19, 2018 (GLOBE NEWSWIRE) – Osmotica Pharmaceutical US LLC (“Osmotica” or the “Company”), a privately-held specialty pharmaceutical company developing novel central nervous sy...
FDA Approves Xadago (safinamide) as an Add-On Treatment for Patients with Parkinson’s Disease
March 21, 2017 – The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking l...
FDA Approves Nuplazid (pimavanserin) for Parkinson’s Disease Psychosis
April 29, 2016 – The U.S. Food and Drug Administration today approved Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis...
FDA Medwatch Alert: Entacapone: Drug Safety Communication - FDA Review Found No Increased Cardiovascular Risks
Including Comtan (entacapone) and Stalevo (entacapone, carbidopa, and levodopa) ISSUE: An FDA safety review has found no clear evidence of an increased risk of heart attacks, stroke, or other...
FDA Approves Duopa (carbidopa and levodopa) Enteral Suspension for Parkinson's Disease
NORTH CHICAGO, Ill., Jan. 12, 2015 /PRNewswire/ – The U.S. Food and Drug Administration (FDA) has approved AbbVie's (NYSE: ABBV) Duopa (carbidopa and levodopa) enteral suspension for the treatment...
Impax Pharmaceuticals Announce FDA Approval of Rytary (carbidopa and levodopa) for Parkinson's Disease
HAYWARD, Calif., Jan. 8, 2015 /PRNewswire/ – Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that the U.S. Food and Drug Administration (FDA) approved...
FDA Medwatch Alert: Benztropine Mesylate Injection (Nexus Pharmaceuticals): Recall - Visible Particulate Matter
ISSUE: Nexus Pharmaceuticals Inc. is recalling two lots of Benztropine Mesylate Injection, USP, 2 mg/2mL (1mg/mL) in 2 mL single dose vials due to the presence of visible particulate matter in the...
FDA Medwatch Alert: Benztropine Mesylate Injection by Fresenius Kabi USA: Recall - Potential Presence Of Glass Particles
ISSUE: Fresenius Kabi USA is voluntarily recalling four lots of Benztropine Mesylate Injection, USP, 2 mg/2mL (1mg/mL) in 2 mL single dose vials due to the potential presence of glass particles...
FDA Medwatch Alert: Mirapex (pramipexole): Drug Safety Communication - Ongoing Safety Review, Possible Risk of Heart Failure
ISSUE: FDA notified healthcare profesionals about a possible increased risk of heart failure with Mirapex (pramipexole). Results of recent studies suggest a potential risk of heart failure that needs...