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.
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. Read More
The Medicines Company expects its Ionsys opioid pain patch to be available in the third quarter of this year, following FDA approval on Thursday. Read More
A federal judge has ruled that the FDA was right in approving generic versions of Otsuka’s blockbuster antipsychotic Abilify, despite exclusivity remaining on at least one indication, removing any final obstacles to market entry of those drugs. Read More
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