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

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

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

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

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

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 ...

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 ...

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

Submission of NDA for LNZ100 in China by CORXEL Pharmaceuticals results in achievement of first milestone due to LENZ under the Development and Commercialization Agreement ...

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

Connect Biopharma's collaborator, Simcere, has submitted a New Drug Application for rademikibart in China, marking a significant step towards potential commercialization in a large market.