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As the FDA’s decision date on GSK’s new drug application (NDA) for daprodustat — its chronic kidney disease anemia drug candidate — approaches, an FDA advisory panel said Wednesday that it favors the drug for kidney patients on dialysis but not for patients who aren’t. Read More
The FDA is falling under the political spell that “more drugs, and faster” is the best way to serve the healthcare needs of American citizens, according to a new report that also criticizes the agency’s lack of transparency and reliance on industry funding. Read More
In a new draft guidance released Thursday, the FDA laid out its thinking on developing drugs that treat Clostridioides difficile infection (CDI), as well as those that prevent and reduce recurrence of the condition. Read More
Acadia Pharmaceuticals has filed three separate patent infringement suits in an attempt to block generic formulations of its only approved drug, Nuplazid (pimavanserin). Read More
The FDA is pushing off or rescheduling several advisory committee meetings this week — including one to consider what could become of the first over-the-counter (OTC) daily oral contraceptive in the U.S., Opill. Read More
Drug manufacturer and outsourcer Nephron SC failed to adequately investigate incidents of cross-contamination between its outsourced operations and its conventional manufacturing line, said the FDA in an especially lengthy and detailed warning letter that cautioned the company against sharing equipment between the two operations. Read More
The World Health Organization (WHO) should include drugs on its essential medicines list regardless of their cost, according to a group of researchers that advocates separating reviews of comparative effectiveness, safety and public health priority from consideration of the price of medicines and their cost-effectiveness. Read More