Gastroesophageal Reflux Disease (GERD)

July 18th 2024

Announced on July 18, 2024, the FDA approval for heartburn relief associated with non-erosive GERD is based on the phase 3 PHALCON-NERD-301 trial.

December 7th 2023

The NDA submission was supported by positive data from the phase 3 PHALCON-NERD-301 study and has been assigned a standard 10-month review with a PDUFA target action date of July 19, 2024.

December 6th 2023

While more studies are needed to ensure the safety of long-term therapy with PCABs, this study establishes a role for the use of vonoprazan in the healing and maintenance of healing in patients with erosive esophagitis.

November 1st 2023

VOQUENZA® provides quicker healing than Lansoprazole, according to an FDA-approved Phase 3 study