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Sen. David Vitter (R-La.), is asking the FDA to process its current backlog of more than 3,000 generic drug applications, especially in light of recent prescription drug price increases. Read More
Japanese regulators are hoping to halve drug review times and speed up patient access to novel therapies by encouraging companies to file NDAs first in Japan, or in tandem with U.S. and EU submissions, under an approval pathway approved in April. Read More
Sandoz says the FDA has accepted its second biosimilar application, this one for a copy of Amgen’s autoimmune disease drug Enbrel, whose global sales of nearly $9 billion made it the world’s fifth-biggest selling medicine in 2014. Read More
The FDA Friday granted Merck’s Keytruda accelerated approval to treat advanced non-small cell lung cancer, making it the first PD-1 inhibitor approved for that indication. Read More
The Senate HELP Committee unanimously passed a bill that would allow drugs to be sold before the Drug Enforcement Agency permanently assigns them to a controlled substance schedule to help extend their marketing exclusivity. Read More
An interim report shows that, since 2013, the FDA has conducted nearly 90 meetings with more than 50 drug companies interested in producing biosimilar products — at a cost of $65.9 million. Read More
The FDA has approved Impax’s generic versions of Valeant’s Mestinon Timespan tablets and Testred capsules, the first two products approved at the company’s Hayward, Calif., manufacturing plant following resolution of a 2011 warning letter. Read More
The European Commission has approved Sanofi and Regeneron’s bad cholesterol treatment Praluent, two months after it was cleared by the FDA for the U.S. market. Read More
Novo Nordisk expects to launch its once daily insulin Tresiba in the first quarter of 2016, following FDA approval of that and another diabetes treatment on Friday. Read More