We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A two-week course of Sage Therapeutics’ investigational antidepressant zuranolone improved symptoms of postpartum depression as quickly as 3 days after initiating treatment, with the benefits sustained up to 45 days, the company said. Read More
The FDA has put the squeeze on Sanofi’s first steps toward an over-the-counter (OTC) version of Cialis (tadalafil), Eli Lilly’s once-blockbuster erectile dysfunction drug. Read More
In an effort to prepare for future health emergencies, the World Health Organization (WHO) has adopted a resolution geared toward delivering higher quality data and improving the conduct and coordination of clinical trials around the world. Read More
Zealand Pharma will bring a new form of its antihypoglycemia drug Zealogue (dasiglucagon) to the FDA as a potential treatment for children with congenital hyperinsulinism (CHI). Read More
SpringWorks unveiled some good news this week with positive topline data supporting its investigational antitumor drug nirogacestat in patients with progressing desmoid tumors. Read More
The FDA updates recommendations for drug development programs and clinical trial designs for antibacterial therapies in a revised draft guidance released yesterday. Read More
Two phase 3 trials presented at Digestive Disease Week in San Diego, May 21-24, confirmed the benefit of immunomodulators in moderate to severe ulcerative colitis (UC). Read More
Troriluzole, Biohaven’s investigational therapy for spinocerebellar ataxia (SCA), didn’t hit its primary endpoint in the topline analysis of its phase 3 study, but the company remains optimistic about some results. Read More
Rocket Pharmaceuticals reported that its trial of a gene therapy targeted toward an aggressive and fatal rare disease in children had a 100 percent survival rate at one year — and the company expects to file for regulatory approval of the treatment in the first half of 2023. Read More
In a congressionally mandated report on diversity in clinical trials, the National Academies of Sciences, Engineering and Medicine (NASEM) recommends the FDA require drug sponsors to file an in-depth recruitment strategy, either before or with their investigational new drug (IND) or investigational device exemption (IDE) applications, that details how they intend to make their trial population reflective of the disease or condition’s demographics. Read More