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Vanda Pharmaceuticals
News

Vanda Pharmaceuticals Reports the US FDA’s NDA Acceptance of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia

Shots:The US FDA has accepted NDA of Bysanti, an active metabolite of iloperidone to treat acute bipolar I disorder & schizophrenia (PDUFA: Feb 21, 2026). If approved, Bysanti may receive 5yrs. of data exclusivity, with pending patents extending into the 2040sNDA is backed by various iloperidone trials, incl. 2 in acute schizophrenia, 1…
May 6, 2025

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Luye Pharma
News

Luye Pharma Launches Erzofri in the US for Schizophrenia and Schizoaffective Disorder

Shots:Luye Pharma has launched Erzofri extended-release injectable suspension in the US to treat adults with schizophrenia & as monotx. or adjunct therapy for adults with schizoaffective disorderErzofri was approved by the US FDA based on a multiple-dose, parallel-group study evaluating its PK profile & relative bioavailability at steady state vs reference product, demonstrating…
April 7, 2025

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Viewpoints_Stella Sarraf
VIEWPOINTS

Enhancing Neurodegenerative Care: Stella Sarraf from Spinogenix in an Enlightening Dialogue Exchange with PharmaShots

Shots: With a broad portfolio of candidates in ALS, Alzheimer’s disease, Schizophrenia, and Fragile X Syndrome, Spinogenix initiated the P-II study evaluating SPG302 for the treatment of patients with Alzheimer’s disease SPG302, a synaptic regenerative therapy, is aimed to provide an effective and patient-friendly solution as a daily pill for ALS and Alzheimer’s disease Today…
October 14, 2024

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Bristol Myers Squibb
News

BMS’ Cobenfy (Xanomeline and Trospium Chloride) Receives the US FDA Approval for Treating Schizophrenia 

Shots:    The US FDA has granted approval to BMS’ Cobenfy for treating schizophrenia in adults, based on its EMERGENT studies The EMERGENT studies comprised of P-III (EMERGENT-2 & 3) trials, evaluating the safety, efficacy & tolerability of Cobenfy vs PBO in schizophrenic adults for over 5wks., as well as two open-label trials assessing long-term safety…
September 26, 2024

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PharmaShots Interview Zai Lab’s Jonathan Wang Shares Insights on KarXT (xanomeline-trospium) for the Treatment of Schizophrenia And Psychosis
VIEWPOINTS

PharmaShots Interview: Zai Lab’s Jonathan Wang Shares Insights on KarXT (xanomeline-trospium) for the Treatment of Schizophrenia And Psychosis

In an interview with PharmaShots, Jonathan Wang, Executive Vice President and Head of Business Development at Zai Lab shares his views on the license agreement with Karuna Therapeutics for KarXT (xanomeline-trospium) to treat schizophrenia and psychosisShots:The companies collaborate to develop, manufacture & commercialize KarXT in Greater China including mainland China, Hong Kong, Macau & TaiwanZai Lab gets exclusive rights to develop &…
February 28, 2022

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