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Beleaguered Indian generics maker Wockhardt said Tuesday it will recall all remaining batches of 12 to 15 products from the U.S. that were manufactured at its Waluj and Chikalthana, India, plants, due to quality concerns. Read More
The FDA on Tuesday gave four drugmakers the green light to market generic versions of Otsuka’s blockbuster Tourette syndrome therapy Abilify, saying a labeling carveout would protect the brand maker’s pediatric exclusivity on the drug. Read More
The latest clinical trial results for Amgen’s talimogene laherparepvec immunotherapy may not be as strong as the company hoped, say FDA advisory committee briefing documents. Read More
Drugmakers in Europe must record and report suspected adverse events that are brought to their attention concerning drugs they donate outside the EU to treat neglected tropical diseases. Read More
Eli Lilly’s targeted antitumor drug Cyramza has snagged its fourth cancer indication from the FDA, this time as a second-line treatment for patients with metastatic colorectal cancer. Read More
Drugmakers in Europe will need to submit proposed educational materials in a specific format and with specified content as part of their risk-mitigation strategy, under a draft addendum to the European Medicines Agency’s good pharmacovigilance practices guidelines. Read More
Nearly three years after generics giant Mylan accused Warner Chilcott and Mayne Pharmaceuticals of “product hopping” with their acne medication Doryx, a federal judge has dismissed the case, ruling in favor of the brandmakers. Read More