The European Medicines Agency (EMA) is considering revisions to its guidance for sponsors of medicines for neonates and is seeking input from stakeholders by Dec. 16. Source: Drug Industry Daily

The FDA slapped Xellia Pharmaceuticals with a Form 483 after finding quality and sterility shortcomings during a May inspection of its Copenhagen facility. Source: Drug Industry Daily

Dozens of patient groups penned a letter to CVS Health’s President and CEO Larry Merlo urging the company to scrap its recently announced plan to deny coverage of drugs that…

Generic drugmakers are suing New York state over its law imposing surcharges on distributors and manufacturers of opioids, arguing the tax disproportionately hurts generic manufacturers. Source: Drug Industry Daily

The FDA flagged UBI Pharma for a slew of violations at its Hsinchu County, Taiwan, facility including inadequate environmental monitoring and sterility practices. Source: Drug Industry Daily

Sen. Claire McCaskill (D-Mo.) called on Nostrum Pharmaceuticals, a drugmaker with facilities in Kansas City, to explain a reported 400 percent price hike in its bladder infection treatment, nitrofurantoin. Source:…

The FDA Friday issued a comment request on obtaining information for evaluating bulk drug substances for use in drug compounding. Source: Drug Industry Daily

FDA Commissioner Scott Gottlieb Friday announced a four-pronged agency initiative to take on antimicrobial resistance, in part by creating incentives for drugs that treat it. Source: Drug Industry Daily

Another impurity has been detected in Zhejiang Huahai Pharmaceuticals’ ill-fated active ingredient valsartan, the FDA announced Thursday. Source: Drug Industry Daily