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The FDA has stepped up its enforcement of compounding pharmacy quality violations that occurred before a new law took effect that boosted agency powers, a move that some industry players contend is unjust. Read More
A former FDA employee plans to press forward with efforts to remove Lasik eye surgery devices from the market following the agency’s denial of his citizen petition seeking the ban. Read More
A federal court has ruled that generic manufacturer Mylan does not have to recall its already-shipped versions of Hospira’s sedative Precedex, a move that reverses the court’s earlier mandate to recall all existing generic versions of the drug. Read More
Teva Pharmaceutical is pulling 3,881 bottles of a generic combination drug to treat Parkinson’s disease because the tablets are potentially “superpotent,” marking another recall for the company this year. Read More
Indian generics maker Dr. Reddy’s Laboratories is under investigation for allegedly selling prescription drugs without sufficient child-resistant packaging, the company revealed. Read More
The FDA has cited two compounding pharmacies for making unapproved and contaminated drugs, and for poor sterile processing practices, the latest indication that the agency won’t let up on larger facilities. Read More
Aegerion Pharmaceuticals said the FDA has closed out a warning letter stemming from overblown claims its CEO made on TV, but the company still faces a federal investigation and lawsuit surrounding its marketing practices. Read More
Taiwan-based TWi Pharmaceuticals has won final FDA approval for a generic version of Par Pharmaceutical’s AIDS drug Megace ES, but the product’s launch remains on hold as the brandmaker appeals its 2011 patent infringement lawsuit. Read More
Biogen Idec said it will launch its multiple sclerosis drug Tecfidera within three months in England and Wales following a final coverage recommendation this week from the UK healthcare pricing watchdog. Read More
Boehringer Ingelheim and Eli Lilly’s type 2 diabetes drug Jardiance has received a preliminary thumbs-down from the UK’s healthcare cost watchdog, which wants to see more cost-effectiveness data comparing the new product with other existing treatments. Read More
Drugmakers operating in Brazil must report all supply chain movements to regulatory authorities in real time, according a new guidance on the country’s drug tracking and tracing system. Read More
GlaxoSmithKline and the National Institutes of Health say they are fast-tracking clinical trials of their experimental Ebola vaccine candidates, and that the drugmaker will make up to roughly 10,000 additional doses of the vaccine so that stocks can be made available immediately if results are positive. Read More