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A federal judge in Delaware has ended an attempt by Gilead Sciences to defend its Lexiscan (regadenoson) cardiac stress agent from generic competition. Read More
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 of failed attempts using other regulatory pathways. 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recommendations for drug development programs and clinical trial designs for antibacterial therapies in a revised draft guidance released yesterday.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
The WHO granted the vaccine an emergency use listing (EUL) in November 2021 but suspended the supply in April following its inspection of the Bharat Biotech facility. Read More
The FDA sent a warning letter to Newbury Park, Calif.-based Colorful Products citing serious quality control violations at the company’s over-the-counter (OTC) drug manufacturing facility. Read More
The FDA approved Sanofi and Regeneron’s blockbuster monoclonal antibody, Dupixent (dupilumab), for patients 12 years and older with eosinophilic esophagitis, a rare chronic inflammatory disorder — making it the first FDA-approved treatment for the disease. 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