The FDA accepted Aldeyra's resubmitted NDA for reproxalap after previous rejections due to efficacy concerns, despite no ...

Johnson & Johnson (NYSE:JNJ) announced on Thursday that the U.S. FDA granted priority review for its new drug application aimed at getting marketing approval for TAR-200, a drug-releasing system for ...

Aldeyra Therapeutics (NASDAQ:ALDX) announced on Thursday that the U.S. Food and Drug Administration (FDA) accepted for review its resubmitted New Drug Application (NDA) for its lead drug reproxalap, ...

An FDA advisory panel will meet July 18 to consider a supplemental new drug application for the antipsychotic brexpiprazole, ...

The new drug application is supported by 48-week data from the Phase III MK-8591A-051 and MK-8591A-052 trials, which showed ...

The Food and Drug Administration (FDA) has accepted the New Drug Application for doravirine/islatravir (DOR/ISL) for adults with virologically-suppressed HIV-1 infection.

Pierre Fabre Pharmaceuticals, Inc. today announced the transfer of the Investigational New Drug Application for tabelecleucel ...

A new report looks at hiring trends © 2025 American City Business Journals. All rights reserved. Use of and/or registration ...

The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...

Aldeyra Therapeutics Submits New Drug Application to the U.S. Food and Drug Administration for Reproxalap for the Treatment of Signs and Symptoms of Dry Eye Disease November 29, 2022 08:00 AM ...

Company announcement – No. 51 / 2024. U.S. Food and Drug Administration issues Complete Response Letter for the glepaglutide New Drug Application for the treatment of short bowel syndrome ...

The application is supported by data from 2 randomized, open-label, multicenter phase 3 clinical studies (NCT04292730 and NCT04292899) conducted by Gilead and a randomized, placebo-controlled ...