April 23rd 2024
Abeona's pz-cel is up for indicated use to treat patients with recessive dystrophic epidermolysis bullosa.
Long Time Coming: Pediatric Gastroenterologists React to New Dupilumab EoE Approval
February 1st 2024Following the January 25, 2024 approval of dupilumab for eosinophilic esophagitis in patients 1-11 years of age, a trio of pediatric gastroenterologists shares their thoughts on the new indication, their anticipated priority of use, and potential hurdles to optimal treatment uptake.
Dupilumab's Role in Managing Pediatric EoE, with Evan Dellon, MD, MPH
January 25th 2024We sat down with Evan Dellon, MD, MPH, to discuss the use of dupilumab in pediatric EoE patients, with the agent gaining FDA approval as the first and only indication for this patient population on January 25, 2024.
On January 23, 2024, Heron Therapeutics announced the FDA had approved its sNDA for bupivacaine and meloxicam extended-release solution to expand the indication to include soft tissue and orthopedic surgical procedures, including procedures in which direct exposure to articular cartilage is avoided.
FDA Accepts Biologics License Application for Ustekinumab Biosimilar DMB-3115
BLA submission was based on data from phase 3 clinical trials in which DMB-3115 showed no clinically meaningful differences compared with the reference product for the treatment of plaque psoriasis.
FDA Approves Eplontersen (Wainua) for ATTRv Polyneuropathy
December 22nd 2023The FDA has approved eplontersen (Wainua) for treating polyneuropathy in adult patients with hereditary transthyretin-mediated amyloidosis, making it the only medication approved for self-administration via auto-injector pen for this condition.
FDA Priority Review Granted to Omalizumab for Adults, Children with Food Allergy
The decision by the FDA is a step closer to omalizumab’s potential approval, making it the potential first medicine to reduce reactions to many different food allergens after accidental exposure.