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

After a decade of development, a Kansas City-based pharmaceutical company is on the brink of submitting its ADHD medication ...

AbbVie is seeking a new way to fight chronic lymphocytic leukemia by combining its oncology drug Venclexta with another ...

The new guidelines aim to streamline India’s drug approvals, improve transparency, and align regulatory practices with global ...

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 ...

Under the Inflation Reduction Act, medications with the same active ingredient will be treated as the same drug for price ...

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 ...

The submission is supported by four Phase III clinical trials, which showed that icotrokinra demonstrated significant skin ...

Potential NIH and FDA cuts could lower the number of new drugs that come to market in the next three decades, according to a ...

The Department of Health and Human Services today issued a notice announcing a 340B Rebate Model Pilot Program as a voluntary ...

The U.S. Food and Drug Administration has approved PTC Therapeutics' oral drug to treat a rare inherited metabolic disorder ...

Sotyktu (deucravacitinib) has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.