Risvodetinib, an experimental oral small molecule Abli Therapeutics is developing for people with untreated Parkinson’s disease, may be one step closer to Phase 3 clinical testing, following a meeting with U.S. regulators. The end-of-Phase 2 meeting’s main goal with the U.S. Food and Drug Administration (FDA) was to…

The U.S. Food and Drug Administration (FDA) has rejected for the second time AbbVie’s application of ABBV-951 (foscarbidopa/foslevodopa) for treating motor fluctuations in adults with advanced Parkinson’s disease. In a complete response letter to AbbVie, the FDA said the decision is based on observations from an inspection…

NKGen Biotech plans to begin clinical testing of SNK01, a natural killer (NK) cell therapy being developed to treat neurodegenerative diseases, in people with Parkinson’s disease, the company announced. This follows a go-ahead by the U.S. Food and Drug Administration (FDA) for an investigational new drug (IND) application…

Supernus Pharmaceuticals has asked the U.S. Food and Drug Administration (FDA) again to approve the apomorphine infusion pump SPN-830 for treating Parkinson’s disease. “We look forward to continuing our effort with the FDA throughout the NDA [new drug application] review process to bring a promising alternative to…

The U.S. Food and Drug Administration (FDA) has approved Boston Scientific’s software called Vercise Neural Navigator 5, which provides visual guidance on how to best program deep brain stimulation (DBS) settings for Parkinson’s disease. The improved software features an enhanced user-friendly interface that presents simplified patient data and…

The U.S. Food and Drug Administration (FDA) has requested more information about the specialized pump used to administer ABBV-951 (foslevodopa/foscarbidopa), an under-the-skin formulation of levodopa/carbidopa, before it will consider approving the therapy for motor fluctuations in people with advanced Parkinson’s disease. The agency’s complete response letter comes 10…

The U.S. Food and Drug Administration (FDA) has put a hold on clinical trials of IkT-148009, an experimental oral therapy that Inhibikase Therapeutics is developing for Parkinson’s disease and other related and non-related conditions. The hold comes just a few months after Inhibikase started dosing Parkinson’s patients…

Green Valley Pharmaceuticals will launch a multi-center Phase 2 clinical trial to investigate its seaweed-based oral compound oligomannate in people with early-stage Parkinson’s disease, according to a press release. This follows the acceptance of Green Valley‘s investigational new drug (IND) application by the U.S Food and Drug…

PharmaTher is seeking regulatory approval to launch a clinical trial of the painkiller ketamine for levodopa-induced dyskinesia — the uncontrolled, involuntary movements that affect as many as 80% of Parkinson’s patients following treatment. The company, which focuses on the research and development of psychedelic pharmaceuticals, has submitted an…

Gocovri (amantadine) has been approved by the U.S. Food and Drug Administration (FDA) as an add-on therapy for off episodes in people with Parkinson’s disease. Adamas Pharmaceuticals, which developed the therapy, announced its approval in the U.S. for Parkinson’s patients currently taking levodopa and/or carbidopa. Off…