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March 02, 2026
Article
The FDA granted Priority Review and accepted a New Drug Application for rusfertide to treat adults with polycythemia vera.
February 27, 2026
Navepegritide, to be marketed as YUVIWEL, is the only FDA-approved treatment providing continuous CNP exposure over its weekly dosing interval.
The long-acting growth hormone is now indicated for children aged 2.5 years and older with Idiopathic Short Stature, born Small for Gestational Age, or Noonan Syndrome.
February 26, 2026
The supplemental New Drug Application submission comes as a result of positive phase 3 data from the CORE and CORE2 trials or olezarsen in 2025.
February 25, 2026
The FDA has approved proprietary desmopressin oral solution formulation ET-600 for the treatment of central diabetes insipidus in children.
Vanda Pharmaceuticals announced the FDA's acceptance of imsidolimab's Biologics License Application for the treatment of GPP.
February 24, 2026
FDA approves dupilumab for allergic fungal rhinosinusitis, supported by phase 3 LIBERTY-AFRS-AIMS data showing reduced symptoms and corticosteroid or surgery use.
February 23, 2026
This approval of the Allurion Gastric Balloon System, incorporating the Allurion Smart Capsule, is indicated for weight loss management for those with obesity.
The FDA has granted both designations to TSRA-196, an in vivo gene editing program from Tessera Therapeutics, for the treatment of PiZZ alpha-1 antitrypsin deficiency.
February 13, 2026
The FDA denied accelerated approval for bitopertin, citing a need for evidence on clinical benefit from the ongoing phase 3 APOLLO trial.
