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The FDA outlined its current thinking on the information sponsors of transdermal and topical delivery systems (TDS) should include in their NDAs and ANDAs in draft guidance released Wednesday. Read More
The FDA published its fall regulatory agenda on Wednesday for upcoming proposed and final rulemakings, including the following planned actions: Read More
In his mostly smooth Senate confirmation hearing on Wednesday, the administration’s nominee for FDA commissioner said there are some indirect actions the FDA could take to lower drug prices, although he demurred on giving a direct example. Read More
The approval brings Glenmark’s portfolio to 162 products authorized for distribution in the U.S., with 46 ANDA’s pending approval, the company said. Read More
The agency determined that it was not reasonable to assume that the market size would remain constant for the first seven years of marketing Sublocade. Read More
The U.S. Patent Trials and Appeals Board has agreed to launch an inter partes review of a GlaxoSmithKline patent aimed at a vaccine component. Read More
The House Judiciary Committee is set to mark up two pieces of bipartisan legislation today that aim to crack down on drugmakers who game the patent system. Read More
The approval is the ninth indication for Imbruvica in Canada, and the first approval for a non-chemotherapy combination regimen for treatment-naïve patients with chronic lymphocytic leukemia. Read More