Contact
searchSearch
HMP Global

FDA Updates FDA Alerts

a rubber stamp says "FDA Approved"
FDA Alerts
FDA Approves Monthly Olanzapine LAI for Adults With Schizophrenia
10/09/2026
Brionna Mendoza
Teva Pharmaceuticals announced the FDA approval of subcutaneous olanzapine (Weltruza) for extended-release injectable suspension on October 9, 2026.
Teva Pharmaceuticals announced the FDA approval of subcutaneous olanzapine (Weltruza) for extended-release injectable suspension on October 9, 2026.
Teva Pharmaceuticals announced...
10/09/2026
Psych Congress Network
US FDA building
FDA Alerts
FDA Authorizes First Digital Therapeutic for Negative Symptoms of Schizophrenia
10/08/2026
Maria Mantas
The US Food and Drug Administration (FDA) granted 510(k) clearance for Motivista, the first treatment specifically authorized for negative symptoms of schizophrenia in adults.
The US Food and Drug Administration (FDA) granted 510(k) clearance for Motivista, the first treatment specifically authorized for negative symptoms of schizophrenia in adults.
The US Food and Drug...
10/08/2026
Psych Congress Network
FDA approval stamp
FDA Alerts
FDA Accepts NDA for AXS-12 in Cataplexy Associated With Narcolepsy
07/16/2026
Maria Mantas
The US Food and Drug Administration (FDA) accepted Axsome Therapeutics’ New Drug Application (NDA) for AXS-12 (reboxetine) for cataplexy in narcolepsy.
The US Food and Drug Administration (FDA) accepted Axsome Therapeutics’ New Drug Application (NDA) for AXS-12 (reboxetine) for cataplexy in narcolepsy.
The US Food and Drug...
07/16/2026
Psych Congress Network
FDA building
FDA Alerts
FDA Clears Personalized Neuromodulation System for PTSD Treatment
06/11/2026
Maria Mantas
The US Food and Drug Administration (FDA) has cleared Wave Neuroscience’s Magnetic EEG-guided Resonance Therapy (MeRT) System, a biomarker-guided neuromodulation technology for the treatment of posttraumatic stress disorder (PTSD).
The US Food and Drug Administration (FDA) has cleared Wave Neuroscience’s Magnetic EEG-guided Resonance Therapy (MeRT) System, a biomarker-guided neuromodulation technology for the treatment of posttraumatic stress disorder (PTSD).
The US Food and Drug...
06/11/2026
Psych Congress Network
A lab tech handles psilocybin research
FDA Update
FDA Vouchers Fast-Track Psychedelic Drugs for Depression and PTSD – Psych Congress Responds With Expert Briefing
04/29/2026
Brionna Mendoza
Following an April 18 executive order, the US Food and Drug Administration (FDA) announced new regulatory actions to accelerate the development of psychedelic-assisted therapy for mental health conditions.
Following an April 18 executive order, the US Food and Drug Administration (FDA) announced new regulatory actions to accelerate the development of psychedelic-assisted therapy for mental health conditions.
Following an April 18 executive...
04/29/2026
Psych Congress Network
FDA approval stamp
FDA Alerts
FDA Approves Lumateperone sNDA With Data Showing Reduced Schizophrenia Relapse Risk
04/27/2026
Maria Mantas
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for lumateperone (CAPLYTA) for relapse prevention in schizophrenia.
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for lumateperone (CAPLYTA) for relapse prevention in schizophrenia.
The US Food and Drug...
04/27/2026
Psych Congress Network
The US Food and Drug Administration headquarters sign.
FDA Alerts
FDA Approves Esketamine as Monotherapy for Treatment-Resistant Depression
01/21/2025
Brionna Mendoza
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for esketamine CIII nasal spray (marketed as Spravato) as monotherapy for major depressive disorder (MDD) in adults who haven’t responded significantly...
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for esketamine CIII nasal spray (marketed as Spravato) as monotherapy for major depressive disorder (MDD) in adults who haven’t responded significantly...
The US Food and Drug...
01/21/2025
Psych Congress Network
The US Food and Drug Administration headquarters sign.
FDA Alerts
FDA Approves Donanemab for Early Alzheimer Disease Treatment
07/02/2024
Brionna Mendoza
The US Food and Drug Administration has issued a highly-anticipated decision: the approval of donanemab—to be marketed as Kisunla by manufacturer Eli Lilly—for the treatment of early Alzheimer disease.
The US Food and Drug Administration has issued a highly-anticipated decision: the approval of donanemab—to be marketed as Kisunla by manufacturer Eli Lilly—for the treatment of early Alzheimer disease.
The US Food and Drug...
07/02/2024
Psych Congress Network

NEW FROM PSYCH CONGRESS NP INSTITUTE

Michael Asbach and Arwen Podesta
Clinical Pearls
Making Lifestyle Interventions Practical and Accessible in MDD Care
10/29/2026
Michael Asbach, DMSc, PA-C; Arwen Podesta, MD
Arwen Podesta, MD, DFAPA, Psych Congress Steering Committee Member, and Mike Asbach, DMSc, PA-C, Co-Chair, Psych Congress PA Institute, discuss practical strategies for incorporating nutrition and exercise recommendations into psychiatric...
Arwen Podesta, MD, DFAPA, Psych Congress Steering Committee Member, and Mike Asbach, DMSc, PA-C, Co-Chair, Psych Congress PA Institute, discuss practical strategies for incorporating nutrition and exercise recommendations into psychiatric...
Arwen Podesta, MD, DFAPA, Psych...
10/29/2026
Psych Congress NP Institute
Michael Asbach and Arwen Podesta
Clinical Pearls
Addressing Lifestyle Factors in Major Depressive Disorder
10/23/2026
Michael Asbach, DMSc, PA-C; Arwen Podesta, MD
How can clinicians incorporate lifestyle interventions into major depressive disorder (MDD) treatment alongside pharmacotherapy?
How can clinicians incorporate lifestyle interventions into major depressive disorder (MDD) treatment alongside pharmacotherapy?
How can clinicians incorporate...
10/23/2026
Psych Congress NP Institute
Kristian Dambrino, DNP, PMHNP-BC
Clinical Pearls
Exploring the Role of Dual-Mechanism and Multimodal Antidepressants in MDD Treatment
10/13/2026
Kristian Dambrino, DNP, APRN, MSN
Kristian Dambrino, DNP, PMHNP-BC, explores the role that dual-mechanism and multimodal medications may play in individualized major depressive disorder (MDD) care.
Kristian Dambrino, DNP, PMHNP-BC, explores the role that dual-mechanism and multimodal medications may play in individualized major depressive disorder (MDD) care.
Kristian Dambrino, DNP,...
10/13/2026
Psych Congress NP Institute

HMP Global Products

Events

HMP Education Logo
HMP Omnimedia Logo
HMP Europe Logo
© 2026 HMP Global. All Rights Reserved.
Cookie Policy Privacy Policy Terms of Use