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Amgen is asking the FDA to require that all biosimilar filers send a full copy of their application to the innovator company, a position that parallels the company’s lawsuit opposing Sandoz’s bid to make a version of its chemotherapy product Neupogen. Read More
The FDA has cleared new prescribing information for Sanofi Pasteur’s Fluzone High-Dose influenza vaccine, indicating it provides improved protection for adults 65 years and older. Read More
Starting early next year, manufacturers will learn faster whether their drug applications have serious quality deficiencies under a sweeping reorganization of CDER’s quality functions into a new “super office.” Read More
FDA advisors have recommended approval of Daiichi Sankyo’s proposed blood thinner to treat certain patients with atrial fibrillation, putting the Japanese drugmaker one step closer to entering a fierce competition to replace the decades-old treatment warfarin. Read More
Makers of influenza vaccines in Europe will have more leeway in what they must submit for products to treat pandemics, according to a final guideline that consolidates procedures for submitting applications for all types of flu vaccines. Read More
AstraZeneca said it plans to launch its new two-in-one diabetes pill Xigduo XR early next year in the U.S. after winning FDA approval this week. Read More
Amgen is suing Sandoz to stop the French drugmaker from marketing a biosimilar of its top-selling product Neupogen in the U.S., charging that Sandoz didn’t follow the rules for biosimilar development. Read More
The FDA approved under its breakthrough therapy designation pathway Pfizer’s meningitis vaccine Trumenba, the first vaccine to prevent a deadly strain of meningococcal disease. Read More