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…
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…
Indian generic drugmaker Sun Pharmaceuticals drew an FDA Form 483 for allegedly falsifying internal documents covering batch records, among other deficiencies, following an agency inspection of the company’s plant in…
The FDA has revised its 2016 draft guidance on charging patients for drugs under investigational new drug applications (IND) in clinical trials or expanded access programs.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…
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…
CSL has posted positive phase 3 topline results for garadacimab, a drug designed to prevent potentially dangerous attacks of swelling related to a rare genetic disorder called hereditary angioedema. Source:…
Colorado has chosen three supply chain partners to help the state import lower-cost medications from Canada, in anticipation of getting the FDA’s approval to launch the program. Source: Drug Industry…
The number of drug units impacted by recalls in the second quarter of 2022 was slashed by more than half — from 435.3 million units recalled in Q1 to 20.6…
Astellas Pharma got an FDA green light last week when the agency accepted its New Drug Application (NDA) for fezolinetant — potentially the first-ever nonhormonal drug for hot flashes associated…
It’s not just academia- and industry-funded trials that are lacking in transparency; a recent audit by the Office of Inspector General (OIG) has found that the National Institutes of Health…