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The nonprofit Institute for Clinical and Economic Review, which analyzes drug prices, said in January that the drug would be cost effective if priced between $16,000 and $20,000 per year.
The U.S. Food and Drug Administration (FDA) on Thursday approved the first new drug to treat people with schizophrenia in more than 30 years. Cobenfy, manufactured by Bristol Myers Squibb ...
The U.S. Food and Drug Administration (FDA) on Friday approved a new drug used for treating schizophrenia in adults, according to a press release. “This drug takes the first new approach to ...
In September 2024, it was approved for medical use in the United States. [1] [2] It is the first antipsychotic drug approved by the US Food and Drug Administration (FDA) to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care. [2] [3]
The Brief Negative Symptom Scale (BNSS) has been used to assess the effect of Ulotaront on the negative symptoms of schizophrenia. [18] In July 2023, the pharmaceutical company behind the drug announced that the drug had failed to outperform placebo in the treatment of acutely psychotic patients with schizophrenia, as measured by the PANSS. [19]
Minerva believed that the findings of this second trial supported the claim that the drug was an effective agent for the treatment of negative symptoms in schizophrenia. However, in October 2022, FDA sent Minerva a refusal to file letter pertaining to the New Drug Application for roluperidone for treating negative symptoms in schizophrenia ...
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