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The FDA dealt Shire’s promising dry eye treatment lifitegrast a setback, requesting an additional clinical study and more product quality information just days before the drug’s anticipated approval date. Read More
A consumer watchdog group is urging the FDA to hold drugmakers to a higher standard when it comes to data to support NDAs, saying the agency’s review of Boehringer Ingelheim’s blockbuster bloodthinner Pradaxa was flawed and dangerous. Read More
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