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The FDA published final guidance on its priority review voucher program for tropical diseases, saying that a voucher does not offer a complete guarantee of an approval within six months. Read More
Sen. Charles Grassley (R-Iowa) is pressing Mylan and the Centers for Medicare and Medicaid Services for answers on the misclassification of the company’s EpiPen as a generic for the agency’s drug rebate program. Read More
The FDA has published 30 new product-specific recommendations on the design of bioequivalence studies for ANDAs, while also revising 30 of its previous recommendations. Read More
Par Pharmaceuticals has sued the FDA for not granting the company 180 days of marketing exclusivity for its first generic of Takeda Pharmaceutical’s Colcrys, asking a federal court to enjoin the agency from approving any competing generics. Read More
The EMA is appealing a temporary injunction from the General Court of the European Union that prevents the agency from releasing a clinical study report on PTC Therapeutics’ Duchenne muscular dystrophy drug Translarna. Read More
Amgen and UCB announced results from a Phase III trial that showed romosozumab significantly reduced the incidence of new vertebral fractures in postmenopausal women with osteoporosis through 12 and 24 months, meeting the study's co-primary endpoints. Read More