Clinical

FDA approves first fast-acting oral drug for clinical depression

FDA approves first fast-acting oral drug for clinical depression

Story at a glance A newly approved treatment for clinical depression is being hailed as a potential game changer for the millions of Americans who suffer from the condition. Auvelity, from Axsome Therapeutics, marks the first drug with a different mechanism of action approved for treating depression in 60 years. In clinical trials, participants reported …

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VistaGen Announces Topline Results from PALISADE-1 Phase 3 Clinical Trial for Investigational Drug PH94B

VistaGen Announces Topline Results from PALISADE-1 Phase 3 Clinical Trial for Investigational Drug PH94B

PH94B for Acute Treatment of Social Anxiety Disorder Did Not Meet Primary Endpoint PH94B Showed a Favorable Safety and Tolerability Profile among Study Participants that was Consistent with Prior Clinical Trial Results SOUTH SAN FRANCISCO, Calif., July 22, 2022–(BUSINESS WIRE)–VistaGen Therapeutics, Inc. (Nasdaq: VTGN) (VistaGen, the Company), a late clinical-stage biopharmaceutical company aiming to transform …

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Biden to tap Harvard surgeon, clinical trials expert as NCI director

Biden to tap Harvard surgeon, clinical trials expert as NCI director

Mon­i­ca Bertag­nol­li, an em­i­nent sur­gi­cal on­col­o­gist and physi­cian-sci­en­tist, is set to suc­ceed Ned Sharp­less as di­rec­tor of the Na­tion­al Can­cer In­sti­tute. Ned Sharp­less Al­though the White House has yet to con­firm the ap­point­ment, mul­ti­ple can­cer re­search or­ga­ni­za­tions and pa­tient ad­vo­ca­cy groups ap­plaud­ed the choice, in­clud­ing AS­CO, where Bertag­nol­li pre­vi­ous­ly served as pres­i­dent. Cur­rent­ly a pro­fes­sor …

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Cogent Biosciences Announces Positive Initial Clinical Data from Ongoing Phase 2 APEX Trial Evaluating Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)

Cogent Biosciences Announces Positive Initial Clinical Data from Ongoing Phase 2 APEX Trial Evaluating Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)

Cogent Biosciences, Inc. All patients treated with bezuclastinib achieved ≥50% reduction in serum tryptase, with a median reduction of 89%, regardless of prior KIT D816V inhibitor treatment All bone marrow biopsy-assessed patients achieved ≥50% bone marrow mast cell reduction and decreases in blood KIT D816V variant allele fraction (VAF) Bezuclastinib demonstrates favorable initial safety and tolerability …

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