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The FDA has delayed Sarepta Therapeutics’ NDA submission for its Duchenne muscular dystrophy (DMD) drug because of a failure in trials of a similar drug. Read More
The FDA says someone hacked into CBER’s online submission system last month and may have put users in danger of having their online personal identity stolen. Read More
The UK’s National Institute for Health and Care Excellence (NICE) has asked Janssen for more information on its multiple myeloma treatment Velcade before an appraisal committee can make final recommendations on its use in patients untreatable with high-dose chemotherapy and haematopoietic stem cell transplant. Read More
Sanofi’s bid to expand the indication for its biologic Lemtrada to treat relapsing multiple sclerosis (MS) faces tough scrutiny by FDA advisors as agency reviewers say data supporting the application point to “serious and potentially fatal safety issues.” Read More