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Patient Care Editorial Staff
Articles
FDA Accepts BLA for Lerodalcibep, Novel PCSK9 Inhibitor to Lower LDL-C
February 10, 2025
The FDA set a PDUFA action date of December 12, 2025 for lerodalcibep, according to LIB Therapeutics.
FDA Grants Priority Review to Brensocatib, First Targeted Treatment for Bronchiectasis
February 07, 2025
The FDA has set the Prescription Drug User Fee Act target action date for bronchiectasis for August 12, 2025, Insmed Incorporated announced.
Early-Phase Trial Launches of VES001 for Gene-Related Frontotemporal Dementia
January 23, 2025
Vesper Bio anticipates completing enrollment and dosing by mid-2025 in the Phase 1B/2A trial for VES001.
FDA Clears Cobas Liat Assay Panels for Point-of-Care Diagnosis of Sexually Transmitted Infections
January 23, 2025
These test panels allow clinicians to diagnose multiple STIs from a single specimen, with results available in about 20 minutes.
Cebranopadol Achieves Positive Phase 3 Results for Treatment of Moderate-to-Severe Acute Pain
January 22, 2025
Cebranopadol, an investigational oral dual-NMR agonist, satisfied the primary endpoint of statistically significant reduction in pain intensity compared to placebo following abdominoplasty surgery.
FDA Approves Esketamine as Monotherapy for Adults With Treatment-Resistant Depression
January 21, 2025
The approval of esketamine follows an FDA Priority Review and is based on data showing that esketamine alone demonstrated rapid and superior improvement in depressive symptoms compared with placebo.
Atogepant May be More Cost Effective vs Rimegepant for Episodic Migraine, According to New, Indirect Comparison
January 21, 2025
Findings of the study support the AHS 2024 statement supporting CGRP inhibitors as first-line options and calling for reducing overall costs of migraine treatment.
Arrivo BioVentures Reports Positive Findings on SP-624 as Potential First MDD Therapy Targeted to Women
January 10, 2025
An earlier phase 2 study found statistically significant improvement of MDD in female participants.
FDA to Convene Advisory Committee on Brexpiprazole-Sertraline for Adult PTSD
January 10, 2025
The adcomm meeting is expected to happen in the first half of 2025, and means the FDA expects to miss the target PDUFA date.
FDA Accepts Protocol for Annovis Bio’s Buntanetap Phase 3 Alzheimer Disease Trial
January 09, 2025
Buntanetap is an oral molecule designed to inhibit the production of multiple neurotoxic proteins and is under investigation for treatment of Alzheimer Disease, Parkinson’s Disease, and other neurodegenerative diseases.