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Patient Care Editorial Staff
Articles
FDA Clears IND for Alphyn’s Zabalafin Hydrogel for Atopic Dermatitis
February 20, 2025
The clearance enables Alphyn to initiate global phase 2b clinical trials, which are anticipated to begin in the first quarter of 2025.
FDA Approves Merilog, First Rapid-Acting Insulin Biosimilar for Diabetes
February 14, 2025
Merilog joins two long-acting insulin biosimilar products approved in 2021, bringing the total to three insulin biosimilars available in the United States.
Cannabis Use Disorder: FDA Grants Fast Track Status to Investigational Agent PP-01
February 13, 2025
The development comes at a time when cannabis use disorder has risen steadily in the United States.
5 Days in Hawaii: The Winter Clinical Hawaii Dermatology Conference
February 13, 2025
The Winter Clinical Hawaii Dermatology Conference will kick off on the Big Island on February 14th. Check out the agenda and the option to attend virtually.
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.