Drug Watch

The FDA has issued a complete response letter to Orexo for OX124, a high-dose naloxone nasal spray for opioid overdose reversal.

Kisunla (donanemab-azbt) is now approved by the FDA for adults with early symptomatic Alzheimer disease.

While ketamine is a not approved for the treatment of depression or chronic pain, clinicians have shown increased interest in using it for these conditions. An FDA workshop is exploring its potential.

June held negative news for psychedelics and an accepted sNDA for brexpiprazole + sertraline for adults with PTSD.

The FDA has approved its supplemental New Drug Application for Wakix tablets for the treatment of excessive daytime sleepiness in pediatric patients aged 6 years and older with narcolepsy.

The FDA has authorized the marketing of 4 menthol-flavored e-cigarette products in the United States through the premarket tobacco product application pathway.

ALTO-101 has previously been shown to positively impact cognition in schizophrenia.

Lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints, according to new study.

Following the vote of the US Food and Drug Administration Psychopharmacologic Drugs Advisory Committee, Lykos has released a statement on MDMA-assisted therapy.

The FDA Advisory Committee recommended donanemab, which could lead to its approval later this year.

Rakesh Jain, MD, shares more about the recent approval of Austedo XR for the treatment of tardive dyskinesia and Huntington disease chorea control.

Investigators have dosed the first participant in a new study investigating the neurophysiological effects of BPL-003.

Research on MDD treatments seltorexant and Spravato (esketamine) CIII nasal spray shared at 2024 ASCP Annual Meeting.

The FDA has approved Austedo XR as a once-daily pill treatment option for tardive dyskinesia and Huntington disease chorea control.

Onyda XR is the first and only liquid nonstimulant ADHD medication approved in the US and the only approved nonstimulant ADHD medication with nighttime dosing.

Sam Clark, MD, PhD, the founder and CEO of Terran Biosciences shared all you need to know about the development of their schizophrenia treatment, TerXT.

Check out new data from phase 3 study of Ingrezza for the real-world management of tardive dyskinesia.

Eisai and Biogen announced they have initiated a rolling submission for subcutaneous Leqembi for Alzheimer disease.

The psilocybin did well on safety and efficacy in this phase 2 trial of patients with PTSD.

TEV-‘749, an investigational once-monthly subcutaneous long-acting injection of the 2nd generation antipsychotic olanzapine, sees positive phase 3 results.

The chief scientific officer and medical director of Segal Trials shares more on KarXT, a first in class for muscarinic agonists, and what he's excited about at the upcoming 2024 APA Annual Meeting.

The new formulation was approved to help patients with tardive dyskinesia who have trouble swallowing.

The addition of 30 mg of evenamide to patients’ current antipsychotic medication was associated with a highly statistically significant reduction in the PANSS Total Score.

Check out new positive topline data from the SAVITRI study assessing the efficacy and safety of NBI-1065845 in adults with major depressive disorder.

Study results suggest the potential for a scalable, single-dose treatment approach.