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A Texas drug compounder is recalling all lots of its sterile drug products after an FDA inspection found it had not investigated failed sterility tests. Read More
The European Commission released new rules clarifying the responsibilities of qualified persons overseeing global, multisite manufacturing operations and the data they need to collect. Read More
The National Institute for Health and Care Excellence has given the green light to Bayer’s Xofigo in England and Wales as an option for treating adults with hormone-relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases, albeit with restrictions. Read More
Pfizer’s proposed merger with Irish drugmaker Allergan is catching flak from some members of Congress who are tying the trend of companies pursuing foreign mergers for tax purposes. Read More
The FDA has hit Life Support Development, a dietary supplement manufacturer and distributor, with a warning letter because its purported “hangover relief” product is considered an unapproved new drug. Read More
The FDA has rejected a single-dose version of AMAG Pharmaceuticals’ hormone injection Makena, requesting additional information from the company before making a decision on the product. Read More
Despite agreeing that Telesta’s bladder cancer biologic candidate would offer limited side effects and low toxicity — maybe even less than standard of care — FDA reviewers voted against recommending it Wednesday because of a lack of proven benefit. Read More