News

After losing 3,500 employees in April—19% of its workforce due to congressional budget cuts—the FDA is now struggling to meet ...
LENZ Therapeutics previously licensed Greater China rights to CORXEL for the development and commercialization of LNZ100 in April 2022.
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 ...
Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include ...
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, ...
Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing ...
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 ...