To help support a global approach to developing new drugs that address antimicrobial resistance (AMR), the European Medicines Agency (EMA) has published a final guideline aimed at aligning data requirements…
To help small entities follow its 2020 final rule on importing prescription drugs from Canada, the FDA released a compliance guide yesterday explaining that U.S. importation programs must show “significant…
West Chester, Pa.-based Verrica Pharmaceuticals drew a second Complete Response Letter (CRL) from the FDA rejecting the company’s New Drug Application (NDA) for its investigational drug VP-102 to treat patients…
Best-selling medicines and drugs cleared under an FDA accelerated approval nab the most FDA-approved new formulations, and this translates to more costs for insurance plans and patients, according to an…
SpringWorks unveiled some good news this week with positive topline data supporting its investigational antitumor drug nirogacestat in patients with progressing desmoid tumors. Source: Drug Industry Daily
A federal judge in Delaware has ended an attempt by Gilead Sciences to defend its Lexiscan (regadenoson) cardiac stress agent from generic competition. Source: Drug Industry Daily
In an unusual legal action, Vanda Pharmaceuticals is suing the FDA in a federal court for denying a request for Fast-Track designation for its investigational drug tradipitant after a series…
The FDA updates recommendations for drug development programs and clinical trial designs for antibacterial therapies in a revised draft guidance released yesterday. Source: Drug Industry Daily
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). Source: Drug Industry Daily
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.…