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Results For "bipolar"

22 News Found

FDA approves Teva’s expanded indication for Uzedy for bipolar I disorder
Drug Approval | October 11, 2025

FDA approves Teva’s expanded indication for Uzedy for bipolar I disorder

UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for use every one or two months for the treatment of schizophrenia in adults


Unichem receives ANDA approval for bipolar disorder drug
Drug Approval | February 28, 2022

Unichem receives ANDA approval for bipolar disorder drug

Divalproex Sodium Extended-Release tablets are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, as monotherapy and adjunctive therapy and prophylaxis of migraine headaches


FDA grants breakthrough status to Laguna's mRNA blood test for schizophrenia diagnosis
News | May 02, 2026

FDA grants breakthrough status to Laguna's mRNA blood test for schizophrenia diagnosis

The move puts a spotlight on one of psychiatry’s most persistent clinical challenges: misdiagnosis and delay


Laguna Diagnostics secures FDA breakthrough tag for mRNA test in psychiatric diagnosis
Healthcare | April 29, 2026

Laguna Diagnostics secures FDA breakthrough tag for mRNA test in psychiatric diagnosis

The company receives approval for blood-based test enabling objective differentiation of schizophrenia and bipolar disorder


Alembic Pharma secures USFDA approval for generic Lamotrigine orally disintegrating tablets
Drug Approval | February 26, 2026

Alembic Pharma secures USFDA approval for generic Lamotrigine orally disintegrating tablets

The approved product is a generic version of the reference listed drug (RLD) Lamictal ODT by GlaxoSmithKline and is indicated for the treatment of epilepsy and bipolar disorder


Lupin launches long-acting Risperidone in US
News | November 17, 2025

Lupin launches long-acting Risperidone in US

This marks Lupin’s first commercial product leveraging PrecisionSphere, a proprietary long-acting injectable (LAI) technology


Teva’s AUSTEDO and AUSTEDO XR demonstrate real-world improvement in patients with tardive dyskinesia
Clinical Trials | November 11, 2025

Teva’s AUSTEDO and AUSTEDO XR demonstrate real-world improvement in patients with tardive dyskinesia

The results demonstrated meaningful reductions in the severity of involuntary movements and notable improvements in patient-reported quality of life


Johnson & Johnson gets FDA nod for new depression treatment
Drug Approval | November 10, 2025

Johnson & Johnson gets FDA nod for new depression treatment

This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials


Sunshine Biopharma launches Olanzapine and Olanzapine ODT
News | January 22, 2025

Sunshine Biopharma launches Olanzapine and Olanzapine ODT

Olanzapine is indicated for the acute and maintenance treatment of schizophrenia and related psychotic disorders


Bristol Myers Squibb completes acquisition of Karuna Therapeutics
News | March 21, 2024

Bristol Myers Squibb completes acquisition of Karuna Therapeutics

KarXT, Karuna’s lead asset, is a potential first-in-class treatment for Schizophrenia