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 ...

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

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 new drug application is supported by 48-week data from the Phase III MK-8591A-051 and MK-8591A-052 trials, which showed ...

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

For example, a cancer patient can now buy a locally produced immunity boosting drug for Tk 7,000-8,000 per pre-filled syringe, while the imported version would cost Tk 85,000-95,000. Experts note that ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include ...

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

An FDA advisory panel will meet July 18 to consider a supplemental new drug application for the antipsychotic brexpiprazole, in combination with sertraline, for the treatment of PTSD.

Researchers at the National University of Singapore (NUS) have found new applications of magnetic field therapy with ...

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

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