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.
An FDA advisory committee delivers a brutal beatdown of Clovis' lung cancer drug rociletinib. It could cost Clovis' CEO his job.
Investors give the side eye to a prediction from Chardan analyst Gbola Amusa that Amicus Therapeutics will be acquired for three times its current market value
Too many investors have a fundamental misunderstanding about the significance of orphan drug designation. I should say, insignificance, because the FDA delineation, on its own, means very little.
Shares of Endo fall as much as 9% Monday in sympathy with Insys Therapeutics, which pre-announced sharply weaker first-quarter sales of its fentanyl painkiller Subsys.
Now that the Allergan-Pfizer merger is off, Allergan CEO Saunders could start shopping again for biotech and smaller pharma companies to fuel his company's growth.
Clovis Oncology is better off if the U.S. Food and Drug Administration rejects its lung cancer drug rociletinib.
Relypsa has hired an investment bank and is exploring a sale following the receipt of offers from a "number of potential buyers," Reuters reports.
Both Allergan and Pfizer could target biotech and drug company acquisitions as a way to fuel future growth.
The extravagant travel-expense payouts to Provectus CEO Craig leaves the company at risk of criminal or civil investigations by the Securities and Exchange Commission.
Vertex's stock price has been cut almost in half since the cystic fibrosis drug Orkambi launched last summer.