We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has agreed to fast track its review of a new indication for AstraZeneca’s blood-thinning drug Brilinta, meaning the therapy could be available for patients with a history of heart attacks by the third quarter of 2015. Read More
The FDA says it plans to provide guidance by year’s end on naming biosimilars, potentially ending much of the confusion over how the products will be labeled and tracked. Read More
Takeda said Wednesday it will pay up to $2.4 billion to settle the majority of U.S. lawsuits involving its diabetes drug Actos, which has been linked to cancer. Read More
Three years after introducing a trio of guidances explaining how sponsors must demonstrate biosimilarity to existing biological drugs, the FDA continues to stress the need for a “stepwise” approach when seeking approval. Read More
Generic and brand drugmakers continue to push for an expedited agency review process with clearly defined timelines for updating drug labels based on safety information, according to comments on the FDA’s proposed drug labeling rule. Read More
Drugmakers seeking approval of products with hormonal effects should submit an assessment with their applications that evaluates whether they would be harmful if released into the environment.
The requirement, spelled out in draft guidance Tuesday, would apply to drugs with estrogenic, androgenic or thyroid activity. Read More
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 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