Oct 18, 2024
Schizophrenia affects approximately 24 million people worldwide, or 1 in every 300 people (0.32%). In adults, this rate is 1 in 222 (0.45%). It is not as widespread as many other mental disorders. Onset occurs most frequently in late adolescence and the twenties, and it occurs earlier in men than in women. Schiz...
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Oct 01, 2024
IntraBio's AQNEURSA Receives Historic FDA Approval for Niemann-Pick Disease Type C Treatment IntraBio Inc. has received approval from the FDA for AQNEURSA (levacetylleucine), marking a significant milestone in the treatment of neurological manifestations of Niemann-Pick disease type C in both adults and pe...
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Apr 15, 2024
Evenamide (NW-3509)– derived from Newron's ion channel program, tackles schizophrenia with its unique mechanism, balancing glutamate levels and blocking aberrant sodium channel activity to restore neuronal function without compromising normal excitability. Evenamide, based on a new concept in treating inadequat...
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Apr 12, 2024
Brilaroxazine, developed by Reviva Therapeutics, exhibits potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia. Brilaroxazine’s pharmacological profile sets it apart from traditional antipsychotics. Operating as a partial agonist at D2/3/4 and 5-HT1A/2A recept...
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Apr 05, 2024
Fifteen years after its first FDA approval for treating schizophrenia with Fanapt (iloperidone), Vanda Pharmaceuticals has achieved another success. Fanapt is a type of antipsychotic medication that deviates from the usual and has been administered to individuals with schizophrenia for their immediate treatment fol...
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Mar 19, 2024
Bristol Myers Squibb Enhances Neuroscience Arm with Karuna Therapeutics Buyout Bristol Myers Squibb has declared the finalization of its purchase of Karuna Therapeutics, Inc. With this acquisition concluded Karuna’s shares are no longer being traded on the Nasdaq Global Select Market, as Karuna is now fully owne...
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May 02, 2023
FDA Grants Priority Review to Luspatercept for First-line Treatment of Anemia in Lower-risk MDS The FDA has granted priority review to a supplemental biologics license application (sBLA) seeking to expand the current indication of luspatercept-aamt (Reblozyl) to include treatment of anemia in patients with very ...
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Jan 17, 2023
FDA Approves Luye Pharma’s Rykindo for Schizophrenia Luye Pharma has received its first FDA approval for Rykindo, an injectable formulation of the antipsychotic risperidone administered every two weeks. Rykindo has been approved by the US Food and Drug Administration for the treatment of schizophrenia as well as...
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Apr 12, 2022
FDA Approves BioXcel’s Agitation Drug Igalmi BioXcel Therapeutics has received FDA clearance for its first drug, Igalmi, as a treatment for agitation in persons with Schizophrenia or Bipolar Disorder. Igalmi (dexmedetomidine) is the first drug approved for this application that comes in the form of a tablet that...
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Nov 01, 2021
Progress is driven by innovation. When it comes to developing novel medications and therapeutic biological products, the FDA's Center for Drug Evaluation and Research (CDER) assists the pharmaceutical sector at every stage of the process. CDER offers scientific and regulatory assistance needed to bring innovative m...
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The Next Wave of Radioligand Therapies: 5 Candidates to Watch
Mar 20, 2026
Emerging TIL Therapies Poised to Broaden the Landscape Beyond AMTAGVI
Mar 06, 2026
BYSANTI Approval Positions Vanda to Compete in the Antipsychotic Market
Mar 02, 2026
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