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The FDA Friday approved a third indication for Bristol-Myers Squibb’s Opdivo, this time to treat metastatic non-squamous non-small cell lung cancer that has progressed during or after platinum-based chemotherapy. Read More
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