Morningstar

NEW DRUG APPLICATION FOR TINENGOTINIB TABLETS ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION

NANJING, China and GAITHERSBURG, Md., Dec. 18, 2025 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the "TransThera") announced that the new drug application for Tinengotinib tablets has been ...
Morningstar

Aldeyra Therapeutics Announces PDUFA Extension of the New Drug Application of Reproxalap for the Treatment of Dry Eye Disease

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced that ...
Seeking Alpha

AbbVie Submits New Drug Application to U.S. FDA for Tavapadon for the Treatment of Parkinson's Disease

Submission supported by data from the Phase 3 TEMPO program that demonstrated symptomatic improvement across the Parkinson's disease spectrum Positive results across all three Phase 3 TEMPO trials ...
C&EN

FDA’s new drug approvals dipped in 2025

46 new molecular entities cleared the agency’s hurdles last year, 4 fewer than in 2024 ...
Seeking Alpha

Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics Initiate Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Zipalertinib for ...

PRINCETON, N.J. and TOKYO and CAMBRIDGE, Mass., Nov. 20, 2025 /PRNewswire/ -- Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc ...