Sanofi top-lined positive clinical data today from its investigational basal insulin, as it seeks to defend its position in this fast-growing segment.
The drugmaker says interim trial data meets FDA review requirements and is hoping for June 2014 approval.
New results from its Phase II safety trial show the LDL-cholesterol lowerer was not associated with a major increase in adverse events vs. standard of care.
An investigational cardiovascular heart drug failed to reduce the risk of heart attack or stroke, a miss which some on Wall Street say raises questions about the drugmaker's ability to deliver in late-stage trials.
Safety reviewers' reservations about the MS drug's risk profile, unveiled in briefing documents ahead of an ad-com meeting, suggest it won't be smooth sailing for the drug in the US.
The drugmaker blasted the price-control agency for being shortsighted and underestimating the industry's role in health and savings.
The drug company is ceasing US distribution and marketing the leukemia drug after the FDA said it was worried about blood clots among clinical trial patients.
The FDA told the drugmaker in a letter before the December PDUFA date that evidence does not support an expanded indication.
The AAP says greater access and education are critical in curbing STIs.
The hep. C drug is safe and effective when used in combination with other therapies, according to information posted by FDA reviewers.