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

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 ...

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

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

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

Corcept Therapeutics Incorporated (NASDAQ:CORT) is a California-based company specializing in cortisol modulation through ...

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 ...

LENZ Therapeutics previously licensed Greater China rights to CORXEL for the development and commercialization of LNZ100 in April 2022.

Johnson & Johnson eyes FDA nod to icotrokinra after phase III studies show strong skin clearance and safety in plaque ...

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

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...