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Pfizer is pressing the FDA to extend the market exclusivity of its combination drug Duavee, following a judge’s ruling that the FDA had inconsistently interpreted the eligibility criteria. Read More
The FDA encouraged additional development in topical treatments for head lice infestation, especially in pediatric populations, due to the genetic resistance to the most common treatments. Read More
The DEA has reduced the amount of Schedule II opiate and opioid medications that can be manufactured in the U.S. next year by at least 25 percent. Read More
NICE is endorsing AstraZeneca’s Forxiga as a treatment for Type 2 diabetes in combination with metformin and a sulfonylurea, marking the agency’s third favorable recommendation for the drug. Read More
A European Parliament committee is proposing that the European Commission promote transparency in private research to foster better access to medicines across the EU. Read More
For years, Mylan has dodged paying the appropriate rebates for its epinephrine auto-injector EpiPen through a misclassification, the Centers for Medicare and Medicaid Services confirmed. Read More
The FDA intends to clarify its expectations for demonstrating the interchangeability of biosimilars with reference products, an FDA official said. Read More