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Valbenazine

This approval was supported by positive results in multiple trials, including the KINECT-HD Phase 3 study and the ongoing KINECT-HD2 open-label extension trial.

Myrcludex B

Myrcludex B is under investigation in clinical trial NCT03546621 (A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination

CX516

Pracinostat

Pracinostat is a novel HDAC inhibitor with improved in vivo properties compared to other HDAC inhibitors currently in clinical trials, allowing oral dosing. Data demonstrate that Pracinostat is a potent and effective anti-tumor drug with...

Azetukalner

Azetukalner is under investigation in clinical trial NCT05718817 (An Open-label Study of XEN1101 in Epilepsy). Azetukalner has a monoisotopic molecular weight of 368.23 Da.

Davesomeran

[L43882] A phase 2 and 3 open-label study in participants 18 years or older who had previously received a two-dose primary series and one booster dose of Moderna COVID-19 Vaccine demonstrated that the

Bosutinib

This approval was based on favorable results obtained from the open-label, randomized, multicenter trial BFORE that showed a significant improvement in major molecular response, defined as a ≤0.1% BCR

Ivacaftor

Ivacaftor (also known as Kalydeco or VX-770) is a drug used for the management of Cystic Fibrosis (CF). It is manufactured and distributed by Vertex Pharmaceuticals. It was approved by the Food and Drug Administration on January 31, 2012...

Foreskin fibroblast (neonatal)

Dermagraft has been combined with [DB10772] to create a drug beneficial to patients with open burn wounds [L2427].

Susoctocog alfa

In a global, prospective, controlled, multi-center Phase 2/3 open-label clinical trial, all patients responded to susoctocog alfa treatment within 24 hours [L1129].