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In a blow to AbbVie’s efforts to head off generic competition on its AndroGel 1%, the FDA said Irish drugmaker Perrigo’s testosterone gel product is bioequivalent and interchangeable. Read More
A key European advisory panel gave positive opinions for Gilead’s Zydelig and Janssen-Cilag’s Imbruvica to treat various forms of rare blood cancers and a new indication for Allergan’s Ozurdex to treat the eye disorder diabetic macular edema. Read More
The FDA is considering letting branded drugmakers reserve a proprietary name for a new product, with the goal of avoiding potential delays by approving permanent drug names well in advance of product launch. Read More
Manufacturers looking to speed up drug approvals in the EU and ensure that their products are covered by payers should initiate parallel conversations with the European Medicines Agency and health technology assessment bodies early in the development process, the EMA says. Read More
British drug giant GlaxoSmithKline has submitted the world’s first application for approval of a malaria vaccine, a product developed in partnership with the Bill & Melinda Gates Foundation and the PATH Malaria Vaccine Initiative. Read More
The FDA approved only the second extended-release opioid painkiller to feature abuse-deterrent properties, and hinted that future products that include such technologies could receive faster regulatory reviews. Read More
The FDA has cleared Gilead’s new treatment for three types of rare blood cancers, potentially creating another blockbuster drug for manufacturer of the hepatitis C treatment Sovaldi. Read More
A trio of European pharmaceutical trade groups is seeking greater clarity around the European Medicines Agency’s initiative to streamline the drug approval process through parallel reviews for both reimbursement and safety and efficacy. Read More
Two pharmaceutical industry groups are welcoming a recommendation by Irish regulators that could allow as many as 34 drugs to be sold through pharmacies without a prescription. Read More
The FDA this week approved the first human recombinant C1-esterase inhibitor product for adolescents and adults with acute attacks of a rare condition called hereditary angioedema (HAE). Read More