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The FDA has approved the first-ever generic of AbbVie’s 20-year-old immunomodulator Restasis for dry eye — Mylan Pharmaceuticals’ cyclosporine ophthalmic emulsion 0.05 percent single-use vials. Read More
The program enables U.S. and EU regulators to engage in scientific discourse with sponsors during the development phase of new medicinal products. Read More
The agency is hoping for useful feedback from sponsors, researchers, investigators, trial participants, product manufacturers, healthcare professionals and the general public. Read More
In its latest annual report on Drug Safety Priorities released yesterday, the FDA’s Center for Drug Evaluation and Research (CDER) noted that much of its focus in 2021 remained on pandemic-related products. Read More
The National Institutes of Health (NIH) will decide this month whether Pfizer’s patent on Xtandi (enzalutamide), a prostate cancer drug’s that’s five times pricier in the U.S. than it is in other countries, is subject to so-called “march-in rights.” Read More
At the FDA’s request, Pfizer and partner BioNTech have asked the agency to expand their Emergency Use Authorization (EUA) for the Comirnaty COVID-19 vaccine to include a two-shot series for children six months to four years old. Read More