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First-in-class therapy approved for schizophrenia

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) for schizophrenia in adults. BMS strikes $14bn deal for Karuna Therapeutics The post First-in-class therapy approved for schizophrenia appeared first on European Pharmaceutical Review.

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Two novel biosimilars approved in EU and US

European Pharmaceutical Review

Eculizumab biosimilar gets positive CHMP opinion The post Two novel biosimilars approved in EU and US appeared first on European Pharmaceutical Review.

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Gilead data lends insight into transforming HIV prevention landscape

European Pharmaceutical Review

Lenacapavir for PrEP was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) in October. This newly released data was presented at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow) and will be published in The New England Journal of Medicine.

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Can Hepatitis C drugs reduce symptoms of PTSD?

European Pharmaceutical Review

“Many people have PTSD, but there [are] few effective pharmacologic treatments and limited drug development for PTSD,” commented Gradus. There are two current medications – sertraline and paroxetine – approved by the US Food and Drug Administration (FDA) for treating PTSD symptoms.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

Marketing 103
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The potential of virtual reality-based therapy for serious mental disorders

Pharmaceutical Technology

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses.

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Psychedelic medicines: are they gaining traction in Europe?

European Pharmaceutical Review

As psychedelics diffused into wider society and recreational use increased, some individuals reported…ongoing symptoms after the drugs had left the body” At a time when psychiatry lacked effective medical therapies, the discovery of LSD was of interest.

Medicine 131