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An Alabama compounder is recalling all of its nonexpired drug products over possible contamination issues and stopped production of sterile compounds after the FDA received reports of adverse events. Read More
Impax Laboratories says the FDA has inspected its Hayward, Calif., manufacturing plant and cleared it of all issues raised in a 2011 warning letter, paving the way for the launch of new drug products. Read More
A consumer watchdog group is urging the FDA to hold drugmakers to a higher standard when it comes to data to support NDAs, saying the agency’s review of Boehringer Ingelheim’s blockbuster bloodthinner Pradaxa was flawed and dangerous. Read More
Investment in the biotechnology sector stagnated in the third quarter of 2015, raising $2.1 billion, according to the latest MoneyTree Report from PricewaterhouseCoopers and the National Venture Capital Association. Read More
A U.S. district court judge handed PhRMA a major victory when he vacated an HHS rule requiring Medicaid discounts on orphan drugs in certain healthcare settings, calling it “arbitrary, capricious, [and] an abuse of discretion.” Read More
The FDA Wednesday placed another Indian active pharmaceutical ingredient maker on its import alert list, adding one of Megafine Pharma sites to 46 other India-based finished drug and API sites whose products are banned from entering the U.S. Read More