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FDA Updates News

US FDA building
News
01/14/2026
Maria Mantas
The US Food and Drug Administration (FDA) has requested the removal of information regarding the risk of suicidal ideation and behaviors (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications.
The US Food and Drug Administration (FDA) has requested the removal of information regarding the risk of suicidal ideation and behaviors (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications.
The US Food and Drug...
01/14/2026
Psych Congress Network
FDA building
News
01/12/2026
Maria Mantas
The US Food and Drug Administration has approved Proliv™Rx, a novel at-home neuromodulation therapy as adjunctive treatment for adults with major depressive disorder (MDD).
The US Food and Drug Administration has approved Proliv™Rx, a novel at-home neuromodulation therapy as adjunctive treatment for adults with major depressive disorder (MDD).
The US Food and Drug...
01/12/2026
Psych Congress Network
FDA approval stamp
News
12/16/2025
Maria Mantas
The US Food and Drug Administration (FDA) has approved the first at-home transcranial direct current stimulation (tDCS) device for the treatment of moderate to severe major depressive disorder (MDD).
The US Food and Drug Administration (FDA) has approved the first at-home transcranial direct current stimulation (tDCS) device for the treatment of moderate to severe major depressive disorder (MDD).
The US Food and Drug...
12/16/2025
Psych Congress Network
FDA approval stamp
News
11/07/2025
Maria Mantas
The US Food and Drug Administration (FDA) has approved lumateperone (CAPLYTA®) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.
The US Food and Drug Administration (FDA) has approved lumateperone (CAPLYTA®) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.
The US Food and Drug...
11/07/2025
Psych Congress Network
US FDA sign
News
10/20/2025
Brionna Mendoza
The US Food and Drug Administration (FDA) has approved risperidone (Uzedy) as a once-monthly extended-release injectable suspension for the treatment of bipolar I disorder (BD-I).
The US Food and Drug Administration (FDA) has approved risperidone (Uzedy) as a once-monthly extended-release injectable suspension for the treatment of bipolar I disorder (BD-I).
The US Food and Drug...
10/20/2025
Psych Congress Network
fda building sign
News
09/11/2025
Brionna Mendoza
The US Food and Drug Administration (FDA) approved on Wednesday the Apollo Transcranial Magnetic Stimulation (TMS) Therapy devices for the adjunctive treatment of major depressive disorder (MDD) in adolescents.
The US Food and Drug Administration (FDA) approved on Wednesday the Apollo Transcranial Magnetic Stimulation (TMS) Therapy devices for the adjunctive treatment of major depressive disorder (MDD) in adolescents.
The US Food and Drug...
09/11/2025
Psych Congress Network
FDA building
News
07/21/2025
Maria Mantas
The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted not to recommend the use of brexpiprazole in combination with sertraline for the treatment of posttraumatic stress disorder (PTSD).  
The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted not to recommend the use of brexpiprazole in combination with sertraline for the treatment of posttraumatic stress disorder (PTSD).  
The US Food and Drug...
07/21/2025
Psych Congress Network
FDA approval stamp
News
07/10/2025
Maria Mantas
The US Food and Drug Administration (FDA) has approved a label update for donanemab-azbt (Kisunla), Eli Lilly and Company’s monthly intravenous amyloid-targeting therapy for adults with early symptomatic Alzheimer disease (AD).
The US Food and Drug Administration (FDA) has approved a label update for donanemab-azbt (Kisunla), Eli Lilly and Company’s monthly intravenous amyloid-targeting therapy for adults with early symptomatic Alzheimer disease (AD).
The US Food and Drug...
07/10/2025
Psych Congress Network
FDA approval stamp
News
05/19/2025
Meagan Thistle
The FDA has approved the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test, the first blood-based diagnostic tool intended to aid in evaluating Alzheimer disease (AD) pathology.
The FDA has approved the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test, the first blood-based diagnostic tool intended to aid in evaluating Alzheimer disease (AD) pathology.
The FDA has approved the...
05/19/2025
Psych Congress Network
FDA building
News
01/28/2025
Meagan Thistle
The FDA has approved a supplemental biologics license application for lecanemab-irmb (Leqembi, Eisai Co., Ltd.; Biogen Inc.), an intravenous treatment (IV) for early Alzheimer disease (AD).
The FDA has approved a supplemental biologics license application for lecanemab-irmb (Leqembi, Eisai Co., Ltd.; Biogen Inc.), an intravenous treatment (IV) for early Alzheimer disease (AD).
The FDA has approved a...
01/28/2025
Psych Congress Network