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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is leading a three-year initiative that seeks to harness the power of social media to report adverse drug events. Read More
Drugmaker OncoMed expects to resume enrollment and dosing of new patients for its experimental cancer drug ipafricept in the coming weeks, after the FDA lifted a partial hold on its clinical trials. Read More
A slew of leaky, deteriorating products, an insect infestation and poor complaint handling resulted in another Form 483 for beleaguered injectables giant Hospira. Read More
More than a year after being warned by the FDA for poor quality, Alexion Pharmaceuticals received a fresh Form 483 for problems surrounding gowning procedures and other quality issues. Read More
Beleaguered Indian generics maker Wockhardt has initiated a voluntary Class II recall of 11,661 bottles of metoprolol succinate, a generic version of AstraZeneca’s blood pressure drug Toprol-XL. Read More
Shuttered Boehringer Ingelheim subsidiary Ben Venue continues to create quality headaches for the German manufacturer with the recall of a chemotherapy drug due to a container defect. Read More
Martin Avenue Pharmacy is recalling all of its unexpired sterile preparations and stopping production of sterile drugs after FDA investigators discovered contaminated products and evidence of poor quality control. Read More
Johnson & Johnson and NewLink Genetics are the latest companies to seek Ebola treatments through accelerated human trials of vaccine candidates, an effort that is getting a boost from a collaboration of international regulatory agencies. Read More
The UK’s drug pricing watchdog is recommending Alexion’s blood disease drug Soliris for a life-threatening blood disorder that affects roughly 200 people in England, although the agency is urging the National Health Service and the company to find ways of reducing the high cost of treatment. Read More