Drug Watch

Leqembi for the treatment of Alzheimer disease has been launched in Austria on August 25, 2025, and will be launched in Germany on September 1, 2025—the first launches in the EU.

Altimmune's pemvidutide gains FDA Fast Track designation for alcohol use disorder.

BioXcel Therapeutics advances BXCL501 for outpatient treatment of agitation in bipolar disorder and schizophrenia, receiving positive FDA feedback in its pre-sNDA meeting discussion.

FDA approves Tonmya, a groundbreaking fibromyalgia treatment, offering hope for pain relief after 15 years without new options.

PharmaTher's KETARx gains FDA approval, paving the way for innovative ketamine treatments in pain management and mental health disorders.

NRx Pharmaceuticals secures FDA Fast Track designation for NRX-100, a preservation-free formulation of intravenous ketamine for suicidal ideation in depression.

Stay updated on key psychopharmacology developments, including new treatments for schizophrenia and breakthroughs in depression therapy.

The FDA has granted a Type C Meeting to Nutriband for their Aversa fentanyl patch, which aims to revolutionize pain management with its innovative abuse-deterrent technology.

Boehringer Ingelheim and Click Therapeutics achieve breakthrough results in treating negative schizophrenia symptoms with investigational prescription digital therapeutic CT-155.

Adial Pharmaceuticals just wrapped a successful end of phase 2 meeting with the FDA and will now advance its innovative treatment for alcohol use disorder, AD04.

Biogen's zuranolone gains positive opinion for treating postpartum depression, promising rapid symptom relief and potential EU approval by 2025.

Check out the pipeline updates from July!

Anavex Life Sciences reveals significant cognitive and functional improvements in early Alzheimer disease patients using blarcamesine, highlighting its potential as a long-term treatment.

The FDA has cleared the IND application for MIRA Pharmaceuticals' Ketamir-2, a promising oral treatment for neuropathic pain, which has shown superior efficacy and safety in preclinical studies.

Cognition Therapeutics reveals promising phase 2 results for zervimesine in treating dementia with Lewy bodies and Alzheimer disease at AAIC 2025.

Cingulate secures a $4.3 million FDA fee waiver for its innovative ADHD treatment, CTx-1301, enhancing patient care with extended efficacy.

Roche unveils promising Alzheimer disease treatments and diagnostic tools, including trontinemab and the Elecsys pTau217 blood test, at the AAIC conference.

Apnimed reveals promising results for AD109, a groundbreaking oral treatment for obstructive sleep apnea.

Positive phase 2 results show that treatment with alixorexton led to statistically significant and dose-dependent improvements in sleep latency among patients with narcolepsy type 1.

BioXcel Therapeutics has submitted an pre-sNDA meeting package for Igalmi's outpatient use, aiming to enhance treatment options for agitation in bipolar disorders and schizophrenia.

Gus Alva, MD, discusses the FDA committee vote on brexpiprazole for PTSD, what it means, and what's next.

The FDA advisory committee votes against brexpiprazole plus sertraline for PTSD, citing insufficient efficacy despite some positive trial results.

Seaport Therapeutics initiates a pivotal study for GlyphAllo, a potential breakthrough treatment for major depressive disorder, with or without anxious stress.

FDA reviewers raise concerns over Rexulti's efficacy for PTSD, highlighting discordant study results ahead of the advisory committee meeting.

The FDA advisory committee will review brexpiprazole for PTSD treatment, which could offer new hope after years without new options.