MIRA Pharmaceuticals announces collaboration with Pharmaseed

Studies will Investigate Antidepressant Properties of Ketamir to Position for Initial IND Application in 2024

Zhimeng Biopharma CB03 receives Orphan Drug Designation from the USFDA

CB03 is a candidate drug for the treatment of ALS and other central nerve system (CNS) diseases

Sumitomo Pharma America launches as new combined organization

SMPA's diverse portfolio includes six marketed products and a robust pipeline of early- to late-stage assets

Granules India received ANDA approval for Venlafaxine ER capsules

Venlafaxine HCl extended-release capsules are indicated for the treatment of: Major Depressive Disorder

Alembic receives USFDA tentative approval for Brexpiprazole Tablets

Zydus receives tentative approval from USFDA for Levomilnacipran Extended-Release Capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India

Zydus receives final approval and 180 days shared exclusivity from USFDA for Brexpiprazole tablets

Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults

JB Pharma gets USFDA approval for its generic Venlafaxine Extended-Release Tablets

This product is based on Osmotic Controlled Release Oral Delivery System technology

Unichem receives ANDA approval for quetiapine extended-release tablets

Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD)

Sage Therapeutics and Biogen initiate rolling submission of New Drug Application for Zuranolone

The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023