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New Drug Application (NDA)

FDA accepts New Drug Application for Eyenovia pupil dilation tech

March 2, 2021 By Sean Whooley

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Regulatory/Compliance Tagged With: Eyenovia Inc., FDA, New Drug Application (NDA)

HART lands market exclusivity, pending FDA approval for artificial trachea

September 8, 2014 By Arezu Sarvestani Leave a Comment

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.

Filed Under: News Well, Regenerative Medicine, Regulatory/Compliance Tagged With: Harvard Apparatus Regenerative Technology (HART), New Drug Application (NDA)

Press Release: Harvard Apparatus Regenerative Technology obtains orphan drug designation from U.S. FDA for HART-Trachea

September 8, 2014 By MassDevice Leave a Comment

Press Release: Harvard Apparatus Regenerative Technology obtains Orphan Drug Designation from U.S. FDA for HART-Trachea

Filed Under: News Well, Regenerative Medicine, Regulatory/Compliance Tagged With: Harvard Apparatus Regenerative Technology (HART), New Drug Application (NDA), Press Release

Avedro application needs more work, FDA says

March 18, 2014 By Arezu Sarvestani Leave a Comment

Avedro application need 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.

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), News Well, Optical/Ophthalmic, Regulatory/Compliance Tagged With: Avedro Inc., New Drug Application (NDA)

Delcath dives again on final FDA denial of liver cancer treatment

September 16, 2013 By Brad Perriello Leave a Comment

Delcath dives again on final FDA denial of liver cancer treatment

Shares of Delcath (NSDQ:DCTH) dropped again yesterday on news of the FDA’s final decision regarding its Melblez Kit liver cancer treatment.

Filed Under: Food & Drug Administration (FDA), News Well, Oncology, Regulatory/Compliance, Wall Street Beat Tagged With: Delcath Systems Inc., New Drug Application (NDA)

pSivida takes another stab at FDA approval for Iluvien

March 27, 2013 By Sony Salzman Leave a Comment

pSivida

Alimera Sciences

It’s been a rocky road for pSivida‘s (NSDQ:PSDV) Illuvien, a drug/device combination for diabetic macular edema, but the company hopes that new trial data will pave the way to regulatory approval in the U.S.

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), News Well, Optical/Ophthalmic Tagged With: Alimera Sciences, New Drug Application (NDA), pSivida Corp.

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May 27, 2022
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