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The FDA has expanded market exclusivity from three to five years on all fixed-dose combination drugs that contain a new active ingredient, bowing to industry pressure for new incentives to develop the costly products. Read More
Indian regulators are establishing a panel of experts to conduct a comprehensive review of existing forms and procedures, and recommend improvements to make the drug application process more user-friendly. Read More
Sponsors of clinical trials for new migraine therapies should focus on enrolling more women of childbearing age early in the drug development process, as more women than men have the condition, according to a new FDA draft guidance. Read More
Two lawmakers wrote to HHS Secretary Sylvia Burwell seeking an analysis of national drug pricing and efforts by the Obama administration to bring rising generic prices under control. The letter is likely a precursor to congressional hearings. Read More
The European Medicines Agency is urging companies developing drugs and vaccines for Ebola to seek orphan designation to hasten the evaluation of applications for products that could help victims of the current outbreak in West Africa. Read More
Spectrum Pharmaceuticals wants an extra four months of market exclusivity on its cancer drug Fusilev, arguing the FDA’s delay in approving the drug’s name entitles it to a revised approval clock. Read More