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A number of factors help explain the less-than-celebratory reaction to the approval of Acadia Pharma's first drug, Nuplazid.
Thursday's parade of deals seem to answer a question that's been bugging health care investors for most of 2016: why haven't retreating biotech valuations sparked an uptick in M&A activity?
Senior FDA officials, most notably Dr. Janet Woodcock, the agency's top drug evaluator, spent a lot of time at Monday's panel making supportive statements about eteplirsen.
Vertex Pharmaceuticals tried to soothe fears about the commercial ramp of its cystic fibrosis franchise by providing Orkambi sales guidance for the first time since the drug launched last summer.
MannKind is drowning in debt and fixed purchasing contracts but the company generates no revenue.
An advisory committee convened by the U.S. Food and Drug Administration is reviewing Sarepta's experimental Duchenne muscular dystrophy drug.
The FDA advisory panel review of Sarepta's DMD drug eteplirsen will be surprising, controversial, volatile, dramatic, newsworthy and memorable.
TheStreet's Adam Feuerstein answers reader questions about biotech stocks.
The news was still negative for eteplirsen, the Duchenne muscular dystrophy drug from Sarepta Therapeutics.
Efforts by insurers to negotiate higher discounts or rebates on specialty pharmaceutical products isn't keeping pace with the price increases pushed through by drug and biotech companies, an analyst says.
Bluebird is trying to use a gene therapy to correct the rare and fatal genetic defect found in boys with CALD.
Chiasma shares are plunging Monday following the U.S. Food and Drug Administration rejection of the company's drug to treat acromegaly, a rare disease of the pituitary gland.
Six patients, all with TRK fusion cancers unresponsive to current therapies, reported tumor shrinkage following treatment with Loxo's drug LOXO-101.
TheStreet's Adam Feuerstein answers reader questions about biotech investing. There were a high number of emails on the upcoming Sarepta FDA advisory panel.
Chiasma is expecting the U.S. Food and Drug Administration to make an approval decision Friday on a new oral treatment for acromegaly, a rare disease of the pituitary gland.