Eyenovia (NSDQ:EYEN) announced today that the FDA accepted its New Drug Aplication for its MydCombi pupil dilation agent. MydCombi is a fixed-combination mydriatic agent for potential use in comprehensive eye exams with a formulation for touchless fixed-combination microdosing in an effort to improve the patient experience, according to a news release. Get the full story at […]
New Drug Application (NDA)
HART lands market exclusivity, pending FDA approval for artificial trachea
The FDA granted Harvard Apparatus Regenerative Technology (NSDQ:HART) 7 years of market exclusivity for its not-yet-approved HART-Trachea.
Press Release: Harvard Apparatus Regenerative Technology obtains orphan drug designation from U.S. FDA for HART-Trachea
Avedro application needs more work, FDA says
Massachusetts ophthalmic devices maker Avedro has some issues to address before the company can move forward with an FDA New Drug Application for its light-based cross-linking product for treatment.
