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Eleven pharmaceutical and biological medicines companies have joined forces to promote the availability of biosimilar medicines, under the aegis of a new Biosimilars Forum. Read More
The FDA increased its generic preapproval inspections by 60 percent between FY 2011 and 2013, but didn’t conduct all those requested by agency reviewers. Read More
An FDA advisory committee Tuesday voted 12 to 1 to recommend approval of the Vertex Pharmaceuticals Orkambi combination therapy for patients 12 years and older with two copies of the most common cystic fibrosis mutation. Read More
The FDA is inviting web developers to tap into publicly available data on adverse drug events, recalls and labeling and assess their impact for drug research. Read More
Reauthorization of the Prescription Drug User Fee Act is officially underway with the FDA’s announcement of a July 15 public meeting to assess the current PDUFA V. Read More
The FDA issued Rockville, Md.-based CXL-USA a warning letter for failing to get agency approval before starting a clinical trial and for lax monitoring of the study. Read More
Takeda said Tuesday that the first patient has enrolled in its global Phase 3 study of ixazomib as a maintenance therapy in newly diagnosed multiple myeloma patients. Read More