Johnson & Johnson (NYSE:JNJ) is one of the best trade‑war resistant stocks to buy now. On July 21, 2025, J&J submitted a New ...

Granted through the small business waiver provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the waiver will ...

The FDA has accepted for review the sNDA for deucravacitinib for the treatment of adults with active psoriatic arthritis.

Shares of Zymeworks were higher after the Food and Drug Administration cleared the company's investigational new drug application for its treatment for liver cancer. The stock rose 8.5%, to $14.46, in ...

After losing 3,500 employees in April—19% of its workforce due to congressional budget cuts—the FDA is now struggling to meet ...

Second antibody-drug conjugate (ADC) to progress into clinical development utilizing our proprietary payload and optimized antibodyPreclinical results demonstrate strong anti-tumor activity and favora ...

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

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

LENZ Therapeutics (NASDAQ:LENZ) said Monday that CORXEL Pharmaceuticals has submitted the new drug application for LNZ100 to the Center for Drug Evaluation of the National Medical Products ...

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 ...

LEXINGTON, Mass.-- (BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration ...

U.S. FDA Accepts Supplemental New Drug Application (sNDA) and Grants Priority Review for NUBEQA® (darolutamide) in Combination with Docetaxel for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) ...