Sovaldi's debut has been marked by plenty of criticism from payers and lawmakers, but the hep. C drug's launch, now confirmed to be the fastest of all time, has also reaped blockbuster sales for Gilead.
Panel chair Randall Flick said QRxPharma "had not provided sufficient evidence to support a claim that Moxduo is safer than morphine or oxycodone."
The FDA designation is for an experimental, inhaled form of ciprofloxacin intended to treat a rare lung condition.
The deal would bring Allergan's Botox and Juvederm under the same roof as Restylane.
The company said it plans to file its rare-disease drug with the FDA later this year, for a 2015 review.
GlaxoSmithKline says it is investigating allegations of employee misconduct. The company said in a statement that the allegations have numbers "very similar to those reported by other companies in our sector."
Pfizer and Teva's settlement puts generic Celebrex on the market by December.
Astellas has settled a False Claims case with the Department of Justice over the 2010-2013 marketing of an antifungal medication. Astellas denies the allegations.
Complete data sets have prompted researchers to say Tamilflu and Relenza fail at their key reason for being: preventing flu pandemics.
Phase-II results indicate Merck's all-in-one HCV oral could put pressure on Gilead.
The FDA issued an official halt, five days after Halozyme stopped the Phase-II trial because of patient stroke information.
The drugmaker is accused of burying cancer risks associated with the diabetes medication.
The regulator has put off the inhaled insulin's PDUFA date by three months.
Phase-III results prompted the drugmaker to pursue a third-quarter filing.
The announcement will create the fifth largest generics drug maker, reports Reuters.
The Swiss drugmaker has scooped up Oryzon's experimental acute myeloid leukemia treatment and private Massachusetts diagnostics firm IQuum.
WSJ's sources say allegations of misconduct are similar to those leveled against the company in China.
The GSK-Pfizer-Shionogi joint venture said it will add HIV med Tivicay to a United Nations patent pool, cutting its price for developing countries and granting access for generics firms.
The drugmaker is ceasing a trial called MAGRIT after it was unable to identify patients who could benefit from MAGE-A3.
The FDA has issued draft guidance that funds FDA inspection of some drug compounders.
The Israel-based drugmaker will try to extend the MS treatment's patent life until September 2015.
A court granted Lilly six more years of patent protection for the almost $3-billion-dollar-a-year cancer drug.
At a hearing today, Public Citizen and the generics industry are sounding off on an FDA proposal that would allow generics firms to update labels, regardless of whether the brand has or hasn't.
The FDA has approved a 24-hour version of Pfizer's heartburn medication.
The Carlyle Group has picked up Johnson & Johnson's Ortho Diagnostics for $4B.
The Bay State is saying no to the controversial prescription painkiller.
The Thousand Oaks, Calif. company says its cholesterol-lowering antibody hit its clinical trial endpoint among rare disease patients.
A rival's late-stage trial results suggest the pain med may have a short market life. The key: an FDA division head's documented willingness to overturn the approval should another pain option surface.
Analysts indicate the earlier-than-expected patent loss will not be a significant upset to Pfizer's present. The drugmaker plans to appeal the decision.
Bayer and Amgen's Onyx subsidiary announce an oncology drug failed a Phase-III trial goal among liver cancer patients.