Zydus receives China's NMPA approval for Venlafaxine ER capsules, 75 mg and 150 mg

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

AbbVie completes acquisition of Gilgamesh Pharmaceuticals' Bretisilocin

Acquisition expands AbbVie's psychiatry pipeline with the addition of a next-generation psychedelic compound currently in Phase 2 development for the treatment of major depressive disorder

FDA approves Alembic’s Paroxetine ER tablets

Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg, are indicated for the treatment of major depressive disorder

Zhimeng Biopharma’s investigational drug approved to begin phase 2 epilepsy clinical trial in China

This approval follows the CDE’s clearance in July of this year for Phase 2/3 clinical studies of CB03-154 in amyotrophic lateral sclerosis

AbbVie to acquire Gilgamesh Pharmaceuticals’ bretisilocin for $1.2 billion

Suven Life Sciences announces first patient randomized in Phase-2b clinical trial of Ropanicant

There is a significant unmet medical need for antidepressants that are effective, rapid onset of action and to be well tolerated

Alembic announces USFDA final approval for Brexpiprazole Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets

Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets

Granules now has a total of 67 ANDA approvals from the USFDA

Suven Life Sciences to present positive results from Phase-2a Proof-of-Concept Study of Ropanicant

The company plans to advance Ropanicant into double-blind, placebo-controlled Phase-2b clinical study in MDD patients, anticipated to start in early 2025