Hanmi Pharmaceutical, a South Korean drugmaker, and partner Amneal Pharmaceuticals are expecting the FDA to approve Hanmi's esomeprazole-strontium as treatment for heartburn. The drug is a generic version of AstraZeneca's Nexium.
South Korea's RNL Bio submitted an investigational new drug application to the FDA for RNL-JointStem, its adipose-based stem cell treatment for osteoarthritis. If the application is approved, the firm could begin midstage trials in the U.S. next quarter. RNL-JointStem has been tested in Phase I and II studies approved by Korean regulators.
The FDA has granted clearance to NDO Surgical to market its Plicator II implant device for the treatment of gastroesophageal reflux disease. A clinical trial showed 80% of patients treated with the device had improved control of GERD symptoms, compared with patients taking proton-pump inhibitor drugs.