All of Wockhardt's U.S. targeted  manufacturing facilities are under some kind of FDA oversight, but the Indian generics maker got a new product approved…

The FDA and the European Medicines Agency have agreed to recognize the plant inspections each does in their own areas.

Thanks to some crafty payer negotiating from GSK, even if Advair generics win approval, it may be a while before they gain serious traction, even if it wins…

Sanofi and Swiss contractor Lonza will share the cost of building a €270 million ($286.3 million) plant to expand capacity for new biologic meds.

South San Francisco-based Portola Pharmaceuticals has snagged $50 million in loans from Pfizer and Bristol-Myers Squibb to help cover the additional costs tied…

A North Carolina company that makes transdermal patches has gotten an FDA warning letter for releasing subpotent transdermal pain patches.

Contract manufacturer Fareva has completed an aerosol plant in Virginia but is considering a second upgrade that would more than double capacity at the…

In the last few years, a number of Western drugmakers have struck deals that will permit local manufacturing of their drugs in Saudi Arabia. U.S. drugmaker…

Sanofi is jumping into the Rituxan biosimilars fray in a potential $200 million-plus deal with JHL Biotech, putting the Taiwan-based drugmaker's new China…

Valeant's business relationships with its distributors are under scrutiny once again, with the latest probe focusing on the remarkable sales performance…

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