FDA and Cingulate Aligned with Filing Requirements for New Drug Application for Lead ADHD Asset CTx-1301 Published May 14, 2025 8:00am EDT ...

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 ...

U.S. FDA Accepts New Drug Application for Merck’s DOR/ISL Once-Daily Two-Drug Regimen for Treatment of Adults with Virologically Suppressed HIV-1.

A New Drug Application (NDA) has been submitted to the Food and Drug Administration for ziftomenib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a ...

Media Innoviva Specialty Therapeutics David Patti [email protected] +1.908.421.5971 GARDP Duncan Graham-Rowe [email protected] +44 7966 413623 Investors Argot Partners innoviva ...

The FDA accepted a new drug application for Brimochol PF for the treatment of presbyopia and set a Prescription Drug User Fee Act date of Jan. 28, 2026, according to a press release from Tenpoint ...

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