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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
The SEC is urging drugmakers to include details of FDA correspondence about products in 8-K disclosure filings, or to post portions of them on their websites, to make sure shareholder communications are accurate. Read More
The FDA will hold a June 5 public hearing at its White Oak, Md., campus to discuss FY 2016 regulatory science research priorities for generic drugs. Read More
The U.S. Court of Appeals for the Second Circuit Monday agreed to hear as soon as possible Actavis’ appeal of a lower court decision requiring it to keep an older formulation of its Alzheimer’s drug Namenda on shelves. Read More