FDA approves Johnson & Johnson’s ketamine-derived nasal spray for depression as standalone treatment
The announcement was welcome news for those with major depressive disorder, affecting an estimated 8.3% of the adult ...
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Trump administration freezes many health agency reports and posts, including those from CDC, FDA
The Trump administration has put a freeze on many federal health agency communications with the public through at least the ...
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FDA grants fast-track designation to myotonic dystrophy type 1 treatment
The FDA has granted fast-track designation to an investigational antisense oligonucleotide to treat individuals with myotonic ...
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FDA approves Spravato as monotherapy for adults with major depressive disorder
The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as ...
FDA Approves Nasal Spray for Depression
The U.S. Food and Drug Administration ( FDA) has approved the use of a nasal spray as a standalone treatment for major depressive disorder, offering a new option for those struggling with ...
Managed Healthcare Executive1d
FDA Approves Spravato Nasal Spray as a Standalone Treatment for Major Depressive Disorder
One-third of folks with major depressive disorder experience treatment-resistant depression (TRD), a condition that makes it ...
BioPharma Dive1d
AstraZeneca, Daiichi’s Enhertu successor gets first FDA OK in breast cancer
The clearance of Datroway comes months after the companies narrowed approval plans in lung cancer and opens up a market ...
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FDA Accepts BLA for RP1 With Nivolumab in Advanced Melanoma
The biologics license application for RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma was accepted by the ...
The American Journal of Managed Care1d
Esketamine Approved by FDA as First Monotherapy for Treatment-Resistent Depression
Esketamine (Spravato; Johnson & Johnson) is now the first and only monotherapy for adults with major depressive disorder (MDD ...
FDA approves standalone use of J&J's ketamine-derived depression treatment
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson's nasal spray, Spravato, to allow it to be used ...
FiercePharma1d
Atara's Ebvallo and pipeline candidate put on clinical hold in US after partner's failed plant inspection
After receiving a complete response letter last week, the other shoe has dropped for Atara Biotherapeutics and its pipeline ...
FDA approves Johnson & Johnson's nasal spray for depression as standalone treatment
The Food and Drug Administration on Tuesday approved Johnson & Johnson's nasal spray to be used alone in adults with a major depressive disorder.