February 23rd 2024
The approval is based upon phase 3 findings from the OUtMATCH study, representing the first treatment for adult and pediatric patients with accidental exposure to 1 or more food allergens.
The FDA approval of Edwards Lifesciences EVOQUE tricuspid valve replacement system for treatment of symptomatic severe tricuspid regurgitation is the first of its kind for a transcatheter therapy.
Following 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.
We 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 25, 2024, the day following the proposed PDUFA goal date, Liquidia Corporation announced the FDA was still reviewing the NDA for pulmonary hypertension with interstitial lung disease for treprostinil inhalation powder (Yutrepia).
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.
On January 19, 2024, the FDA announced the addition of a Boxed Warning to the labeling of denosumab (Prolia), citing evidence of an increased risk of severe hypocalcemia in patients with chronic kidney disease.
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.
The 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.
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.
The New Drug Application submission is supported by data from a pair of phase 3 studies, a long-term open-label study, and prior phase 2 studies. Cymabay has also requested Priority Review of the NDA.