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Paxlovid is authorized for treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 years of age and older weighing at least 40 kg. Read More
Days after announcing a bankruptcy filing to restructure more than $8 billion in debt, Endo International has lost a long-contested patent lawsuit, piling more woes on the beleaguered company. Read More
The role of FDA advisory committees is “malleable” and the public would trust the FDA more if the agency aligned its decisions on drug approvals with the decisions by the expert panels. Read More
Morton Grove Pharmaceuticals (MGP), a division of Mumbai, India-based generics maker Wockhardt, is shutting down operations at its plant in a suburb of Chicago after receiving a court order from the Department of Justice (DOJ) telling it to stop making allegedly adulterated medicines there. Read More
A Delaware federal judge has ruled that a planned generic from Teva Pharmaceuticals infringes on a patent on Vifor Fresenius Medical Care Renal Pharma’s Velphoro (sucroferric oxyhydroxide), a chewable tablet that’s used to control phosphate levels in the blood of chronic kidney disease patients on dialysis. Read More
The FDA has revised its 2016 draft guidance on charging patients for drugs under investigational new drug applications (IND) in clinical trials or expanded access programs. The updates, which pertain mostly to expanded access, include additional recommendations on distributing first year costs and submitting statements from independent accountants. Read More
The FDA’s accelerated approval program has come under fire again, this time from a group of researchers that found only 38.9 percent of new drugs green-lighted via accelerated approval demonstrated high therapeutic value when compared with existing therapies. Read More