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Takeda scored a legal victory last week when an Illinois jury found the drugmaker wasn’t responsible for a man’s death while he was on the diabetes drug Actos. Read More
Injectable drug maker Hospira has issued a voluntary recall of dobutamine injection, USP, after a customer complaint of discoloration in a single vial of the heart disease drug. Read More
The FDA blasted generic drugmaker Alvogen for a promotion of the alcoholism treatment disulfiram that omitted potentially life-threatening risks. Read More
An FDA study of postmarket reports shows that Boehringer Ingelheim’s blood thinner Pradaxa presents an increased risk of major gastrointestinal bleeding but a lower risk of strokes and deaths compared with warfarin. Read More
Teva is making a last-second attempt to delay generic versions of its multiple sclerosis drug Copaxone from hitting the market, asking a federal court to require ANDA seekers to submit more data. Read More
The FDA has released a proposed rule that would allow it to destroy certain drug imports that have been refused admission into the U.S., the agency’s latest attempt to boost the integrity of the U.S. drug supply chain. Read More
The FDA slammed biologic manufacturer Greer Laboratories in a warning letter for extensive quality problems, including the presence of pests in its manufacturing plant, and making unapproved allergenic extracts. Read More
A federal appeals court has ruled that generic manufacturers of Merck’s osteoporosis drug Fosamax cannot be held liable for “design defect” claims against the product. Read More
European drug regulators saw a 30 percent increase in adverse drug reaction (ADR) reporting in the EU following the implementation of massive pharmacovigilance legislation in 2012. Read More
The FDA says there isn’t enough evidence to support marketing aspirin as preventing first-time heart attacks, meaning drugmakers will have to fund more studies if they want to change the agency’s mind. Read More