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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
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
In response to overwhelming requests from industry, the FDA is extending to June 8 the comment period on its draft rule overhauling the ANDA and 505(b)(2) approval processes. Read More
Boehringer Ingelheim should see an FDA decision on its idarucizumab blood-thinning antidote by October, following receipt of priority review late this week. Read More
The FDA plans to discontinue accepting paper submissions from drugmakers submitting promotional materials for prescription drugs and offers guidance on how to submit such information using the electronic common technical document. Read More
Biosimilars manufacturers are looking to the FDA for official guidance on several aspects of regulation, including naming and interchangeability. Read More