FDA approves standalone use of J&J's ketamine-derived depression treatment
The U.S. Food and Drug Administration has expanded the approval for Johnson & Johnson's nasal spray Spravato to allow its standalone use in patients with depression, the company said on Tuesday. The drug was previously approved in combination with antidepressants to treat symptoms in adults with major depressive disorder (MDD) who experienced suicidal thoughts or actions.
FDA approves Johnson & Johnson’s nasal spray for depression as standalone treatment
Spravato is now the first-ever standalone therapy for treatment-resistant depression, and is on its way to becoming a blockbuster product.
US FDA approves J&J's ketamine-based therapy to treat depression
The U.S. Food and Drug Administration approved Johnson & Johnson's ketamine-based nasal spray Spravato, to treat adults with major depressive disorder, the company said on Tuesday.
Johnson & Johnson Gets FDA OK For Spravato as Monotherapy
J&J on Tuesday said the green light makes Spravato the first and only monotherapy for adults with major depressive disorder who have had an inadequate response to at least two oral antidepressants.
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How the FDA and CMS worked together on a new approach to paying for digital mental health treatments
By establishing coding and separate payment for certain digital mental health devices, this group from CMS and the FDA hopes to improve access to care.
GH Research Achieves Key Milestones in Depression Trials and Prepares FDA Response
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Colorado House committee advances psilocybin bill, pending FDA approval
The House Health and Human Services committee nearly unanimously approved a bill that would legalize synthetic psilocybin medications for certain conditions, contingent upon approval by the FDA.
J&J's ketamine-based nasal spray Spravato approved by US FDA to treat depression
The FDA approved Johnson & Johnson's Spravato, a ketamine-based nasal spray, to treat adults with major depressive disorder who have not responded to at least two oral antidepressants. This approval addresses the need for new options for treatment-resistant depression,
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Axsome bounces back as FDA clears depression drug
Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. The FDA has cleared ...
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AbbVie adds to Vraylar data as FDA considers depression use
AbbVie has reported new phase 3 data for its schizophrenia and bipolar disorder therapy Vraylar in treatment-resistant depression, as it waits for a decision by the FDA on the new indication.
Sage sues Biogen in wake of $469M buyout offer: report
Sage (SAGE) is reportedly suing Biogen (BIIB) over enforcement of a standstill agreement in the wake of an unsolicited takeover bid valued at around $469M. Read more here.
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Pristiq vs. Effexor: How Do They Compare?
Pristiq (desvenlafaxine) and Effexor (venlafaxine) are SNRIs. Pristiq treats depression, while Effexor treats depression and anxiety disorders.