A manufacturing facility that Integra Skin Sciences picked up last year as part of its deal to buy Valeant’s Groupe Cosméderme dermatology brands has been…

The FDA this year delayed the approval of six new drugs this year because of manufacturing matters, five of which were the subject of complete response letters…

Manufacturing issues have pushed the expected approval of Roche’s experimental drug for multiple sclerosis to next year, one of six drugs delayed this year for…

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…

Akorn, which had a sterile manufacturing plant in Decatur, IL slapped around by FDA inspectors last summer, said the FDA just came back for a re-inspection and…

A Spanish API maker was criticized in an FDA warning letter for poor cleaning procedures, as well as for issues with equipment that was repaired with materials…

Sun Pharma acknowledged today that a recently completed FDA reinspection of it key plant in Halol, India, ended with more citations.

Sandoz and the FDA struck a deal earlier this year to let the generic unit of Novartis import from a Canadian plant an infant parenteral nutrition product…

The FDA has issued a warning letter to a Chinese heparin maker for some of the same kinds of issues raised by the EU earlier this year.

Regulatory