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 ...

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 ...

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

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 ...

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 ...

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.

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 ...

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

The FDA accepted a new drug application for Brimochol PF for the treatment of presbyopia and set a Prescription Drug User Fee Act date of Jan. 28, 2026, according to a press release from Tenpoint ...

U.S. FDA Accepts New Drug Application for Merck’s Doravirine/Islatravir, an Investigational, Once-Daily, Oral, Two-Drug Regimen for Treatment of Adults with Virologically Suppressed HIV-1 Infection.