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The FDA is seeking feedback on the chemistry, manufacturing and controls information that it wants drugmakers to include in INDs for gene therapies containing microbial vectors. Read More
European regulators have granted accelerated assessment for GlaxoSmithKline’s antiseptic chlorhexidine gel for the prevention of umbilical cord infections. Read More
Sen. David Vitter 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
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 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