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The agency is concerned that the amount and frequency of doses given to patients were subject to investigator discretion and often inconsistent. Read More
Two FDA advisory committees voted late Wednesday to recommend approval of Amgen’s talimogene laherparepvec immunotherapy for patients with metastatic melanoma, overriding FDA reviewers’ concerns that results from a pivotal clinical trial were skewed. Read More
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
Mylan has settled patent litigation related to Pfizer’s Viagra, paving the way for generic copies of the erectile dysfunction blockbuster in the U.S. in 19 months. 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
The FDA is seeking specific suggestions on potential changes to the Generic Drug User Fee Act Performance Goals and Procedures, ahead of negotiations to reauthorize the law, which expires Sept. 30, 2017. 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
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The requirement, spelled out in draft guidance Tuesday, would apply to drugs with estrogenic, androgenic or thyroid activity.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
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