JanuaryThe FDA approves the esketamine nasal spray Spravato as a monotherapy for adults with treatment-resistant depression. Spravato had been previously approved for use alongside an oral antidepressant.
The FDA approves the sodium channel blocker Journavx (suzetrigine) for treatment of moderate to severe acute pain in adults.
February
The FDA approves Onapgo, a subcutaneous infusion formulation of the dopamine agonist apomorphine, for treatment of motor problems in adults with advanced Parkinson’s disease.
The FDA approves Onapgo, a subcutaneous infusion formulation of the dopamine agonist apomorphine, for treatment of motor problems in adults with advanced Parkinson’s disease.
March
The FDA expands the clearance of the Horizon Inspire and 3.0 Transcranial Magnetic Stimulation (TMS) systems, now making them available as adjunct therapies for adolescents aged 15 to 21 with major depressive disorder.
April
The FDA approves Mezofy, an oral film formulation of aripiprazole, for the treatment of schizophrenia in patients ages 13 and older.
The FDA approves Mezofy, an oral film formulation of aripiprazole, for the treatment of schizophrenia in patients ages 13 and older.
The FDA expands the marketing clearance for Freespira—an at-home prescription treatment device for panic attacks and posttraumatic stress disorder—to include adolescents ages 13 to 17.
May
The FDA clears the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio—the first blood test for use in the assessment of potential Alzheimer’s disease. The Lumipulse is intended for adults ages 55 and older presenting at a specialized care clinic with signs and symptoms of cognitive decline.
The FDA clears the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio—the first blood test for use in the assessment of potential Alzheimer’s disease. The Lumipulse is intended for adults ages 55 and older presenting at a specialized care clinic with signs and symptoms of cognitive decline.
June
The FDA approves Arynta, an oral solution of the stimulant lisdexamfetamine, for treatment of ADHD and binge eating disorder in patients ages 6 and older.
The FDA approves Arynta, an oral solution of the stimulant lisdexamfetamine, for treatment of ADHD and binge eating disorder in patients ages 6 and older.
August
FDA approves Tonmya (cyclobenzaprine hydrochloride) sublingual tablets for the treatment of fibromyalgia in adults.
FDA approves Tonmya (cyclobenzaprine hydrochloride) sublingual tablets for the treatment of fibromyalgia in adults.
The FDA approves Leqembi IQLIK, a weekly, at-home subcutaneous autoinjector of lecanemab, for individuals with early Alzheimer’s disease who have completed an 18-month regimen of intravenous lecanemab.
The FDA grants an expansion for the MagVenture TMS Therapy system as an adjunct in adolescents ages 15 to 21 with major depressive disorder.
September
The FDA approves Subvenite, an oral suspension of the anticonvulsant lamotrigine, for the treatment of epilepsy and bipolar disorder.
The FDA approves Subvenite, an oral suspension of the anticonvulsant lamotrigine, for the treatment of epilepsy and bipolar disorder.
October
The FDA clears another blood test to aid in the assessment for Alzheimer’s disease—the Elecsys pTau181 Test. It’s also intended for patients ages 55 and older presenting with signs, symptoms, or complaints of cognitive decline, but may be used in primary care settings.
The FDA clears another blood test to aid in the assessment for Alzheimer’s disease—the Elecsys pTau181 Test. It’s also intended for patients ages 55 and older presenting with signs, symptoms, or complaints of cognitive decline, but may be used in primary care settings.
The FDA approves the use of Uzedy, a long-acting injectable of risperidone, as a monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.
November
The FDA adds another indication for Caplyta (lumateperone), approving the second-generation antipsychotic as an adjunct to antidepressant therapy for adults with major depressive disorder.
The FDA adds another indication for Caplyta (lumateperone), approving the second-generation antipsychotic as an adjunct to antidepressant therapy for adults with major depressive disorder.
The FDA clears the Deep TMS system for use as an adjunct therapy for adolescents ages 15 to 21 with major depressive disorder.
December
The FDA clears a prescription version of the Lumosity brain training platform; the LumosityRx app is authorized for adults ages 22 to 55 with ADHD.
The FDA clears the Fl-100, an at-home transcranial direct current stimulation device, for the treatment of moderate to severe major depressive disorder.
(Image: Getty Images/iStock/Grandbrothers)
