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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recommendations for drug development programs and clinical trial designs for antibacterial therapies in a revised draft guidance released yesterday.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
The FDA has approved use of Celgene’s chemotherapy Vidaza (azacytidine) in advance of stem cell transplant for children newly diagnosed with a rare form of leukemia. Read More
About 100 generic medicines are likely to get their European marketing authorizations yanked following revelations of flaws in their bioequivalence studies conducted at one particular contract research organization. Read More