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With only 14 compounding facilities having volunteered for FDA oversight in two months, the agency is now asking hospitals and state authorities to get behind the registration effort. Read More
The FDA wants IND sponsors to stop the practice of routinely using age limits as exclusion criteria for clinical trials and increase the number of patients with multiple chronic conditions included in drug studies. Read More
The FDA on Feb. 1 will begin sending status updates to all drugmakers with pending ANDAs to allow them to better estimate when their products can launch. Read More
After a tough 2013, Teva received some good news Tuesday in the form of a newly approved formulation of its blockbuster drug Copaxone, helping the product gain new market share as Teva fights off generic competition. Read More
A New Jersey federal judge Friday dismissed a pay-for-delay case involving a “no-authorized generic agreement” between GlaxoSmithKline and Teva, saying the Supreme Court’s landmark 2013 ruling in Federal Trade Commission v. Actavis applies antitrust scrutiny only to pay-for-delay deals that involve money. Read More
As part of its continuing effort to improve the ANDA approval process, the FDA is again focusing attention on the quality of ANDA submissions, this time asking industry for help. Read More
UK regulators plan to reimburse drugmaker Astellas for its prostate cancer drug Xtandi (enzalutamide), but not in patients who have already been treated with Janssen’s Zytiga (abiraterone). Read More