New GlaxoSmithKline lung drug nabs thumbs-up from FDA experts

Tracy Staton An FDA advisory panel gave an approval stamp to GlaxoSmithKline's ($ GSK) new lung drug, Breo. The agency advisers weren't unanimous in backing GSK's follow-up ...

FDA denies inhaled migraine drug from Allergan

Ryan McBride Allergan ($ AGN) lost the latest bid for FDA approval of an inhaled version of the long-used drug dihydroergotamin for acute migraines. The U.S. regulator handed Allergan, ...

Drugmakers ‘illegally’ withhold samples from would-be copycats

Tracy Staton Risk-management plans may be a burden for new drug launches, but they're proving to be a weapon against generic competition, too. As the New York Times reports, generics ...

AbbVie to hack hundreds of reps from cardiovascular sales ranks

Tracy Staton AbbVie has a new distinction. It may be the youngest pharma company ever to lay off hundreds of salespeople. Bloomberg reports that the drugmaker, spun off by Abbott Laboratories ...

FDA seeks more data from Sarepta to decide on accelerated approval

Ryan McBride Sarepta Therapeutics ($ SRPT) has kept hopes alive for gaining accelerated approval for its lead drug eteplirsen for Duchenne muscular dystrophy. Yet the FDA wants additional ...
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