U.S. FDA Accepts New Drug Application for Merck’s Doravirine/Islatravir, an Investigational, Once-Daily, Oral, Two-Drug Regimen for Treatment of Adults with Virologically Suppressed HIV-1 Infection.

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

The FDA accepted a resubmitted new drug application for reproxalap, a first-in-class investigational topical therapy for dry ...

Aldeyra Therapeutics (NASDAQ:ALDX) announced on Thursday that the U.S. Food and Drug Administration (FDA) accepted for review ...

Johnson & Johnson (JNJ) said on Tuesday that it has submitted a supplemental new drug application to the U.S. Food and Drug Administration based on data evaluating the efficacy of its oral drug ...

Aug. 8 -- Drug maker Bayer pulled its popular cholesterol-lowering medication off the market today amid reports of a deadly side effect. According to the Food and Drug Administration., Bayer ...

The Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for ND0612 for the treatment of motor fluctuations in patients with Parkinson disease ...