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The House Energy and Commerce Committee has released a new draft of its 21st Century Cures Act that would encourage greater use of observational studies, patient registries and real-world therapeutic use to support approvals of new drugs and improve postmarket surveillance. Read More
Republicans on the Senate HELP Committee are taking the FDA to task for failing to shore up policies on biosimilar naming and interchangeability before approving the first biosimilar drug nearly two months ago. Read More
Manufacturers of over-the-counter antiseptics used in healthcare settings will need to submit new safety data to the FDA if they want to keep their products on the market, the agency said Thursday, citing growing concerns about the systemic effects of long-term exposure to certain active ingredients. 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
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
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
Teva is asking the U.S. Supreme Court to overturn a Pennsylvania state court ruling that would let individuals sue generics makers for failing to promptly update their labels in response to new safety concerns, a move some experts say directly contradicts federal statutes. Read More
European regulators are looking to industry for suggestions on the best ways to get generic versions of topical drugs approved without having to conduct time-consuming and expensive clinical trials to prove bioequivalence. 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