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Hospira will have to delay the opening of its new Visakhapatnam, India, plant because of persistent problems turned up during FDA inspections of the facility. Read More
Bristol-Myers Squibb's cancer drug Opdivo has gained a new indication as a second line treatment for metastatic squamous non-small cell lung cancer that has progressed after platinum-based chemotherapy. Read More
Two state legislatures are considering biosimilar substitution bills, but are taking opposite approaches to the issues of prescriber notification and patient consent. Read More
A federal judge has sided with a Paragraph IV ANDA from Teva and struck down the patents protecting Actavis subsidiary Warner Chilcott’s postmenopausal osteoporosis drug Atelvia. Read More
Republican lawmakers warned the FDA on Wednesday to expect fiscal year 2016 funding levels to be in line with this year’s $4.4 billion, not the full $4.9 billion in funding that President Barack Obama asked for in his budget request. Read More