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The FDA has granted rare pediatric disease designation to another investigational drug to treat Duchenne muscular dystrophy, this time to Marathon Pharmaceuticals’ deflazacort. Read More
The FDA has granted priority review status for three sNDAs for Bristol-Myers Squibb’s Daklinza, potentially expanding the firm’s footprint in the roughly $13 billion U.S. hepatitis C market. Read More
Alkermes is preparing to launch its schizophrenia drug Aristada in the U.S. following FDA approval Monday — making it the latest generic to threaten Otsuka’s grasp on the multibillion dollar antipsychotics market via Abilify. Read More
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