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Mylan is expanding its nationwide recall of injectable gemcitabine and methotrexate to the hospital and user level, recalling eight more lots of the drugs after foreign matter was seen during quality control tests. Read More
Shire’s blockbuster attention deficit hyperactivity disorder drug Intuniv is facing competition as four generic versions of the therapy hit the U.S. market. Read More
The FDA is withdrawing approval of one NDA and four ANDAs for ondansetron, effective immediately, due to a potentially life-threatening complication with the drug. Read More
The International Academy of Compounding Pharmacists is urging Congress to require the FDA to revise a memorandum of understanding outlining how states should regulate small compounders, saying the 30 percent a month limit on units sent to other states is unfair and unworkable. Read More
Amgen’s injectable Repatha proved effective in lowering bad LDL cholesterol in a series of Phase 3 trials, but the FDA says some safety concerns remain. Read More
Democratic members of the House Energy & Commerce Committee are pressing the FDA to expand the black box warning on extended-release opioids to include immediate-release versions of the painkillers as well. Read More
Orexigen Therapeutics and Takeda filed a patent infringement suit in federal court aimed at blocking Actavis from marketing a generic version of their anti-obesity drug Contrave. Read More
The European Medicines Agency issued revised guidance on classification of advanced therapy medicinal products and the information that sponsors need to submit to the agency. Read More
Sanofi and Regeneron’s biweekly injectable Praluent effectively lowers bad LDL cholesterol and has few side effects, the FDA says in briefing materials released ahead of a Tuesday advisory committee meeting. Read More