This submission represents the third accepted application for ivonescimab in China, following previous filings for its combination therapy in EGFR-TKI resistant locally advanced or metastatic ...

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

Neurizon submits a formal response to the US FDA addressing a clinical hold on its investigational new drug (IND) application ...

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

The rapid emergence and re-emergence of viral pathogens—exemplified by outbreaks of influenza, Ebola, Zika, and, most recently, SARS-CoV-2—underscore the ...

Bayer said the Food and Drug Administration extended the review period for its new drug application of elinzanetant, a treatment for moderate to severe vasomotor symptoms, also known as hot flashes, ...

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

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

These updates support Ocugen in its efforts to pursue its goal of 3 biologics license applications (BLA) in the next 3 years.

The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment ...

"The reason we chose the technique that's being used is because it can be about as sensitive as a dog in detection," said ...

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