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The FDA is investigating reports that emergency contraceptives such as Teva’s Plan B One-Step lose effectiveness in women over 165 lbs. and don’t work at all for women over 175 lbs. Based on its review, labeling changes for the drugs may be forthcoming. Read More
The EMA has put Boehringer Ingelheim's hepatitis C drug candidate faldaprevir on a speedy review pathway based on studies involving 3,300 patients. Read More
Three years after placing heavy restrictions on GlaxoSmithKline’s type 2 diabetes drug Avandia, the FDA said Monday it is relaxing those restrictions in line with its advisers’ recommendations. Read More
Drugmakers have 14 additional calendar days to comment on recently revised GDUFA question-and-answer guidance after technical difficulties prevented stakeholders from submitting comments on Regulations.gov. Read More
Finalized guidance on preclinical considerations for gene and cellular therapies, posted Monday, reiterates the agency’s position that sponsors should focus on five objectives in preclinical trials. Read More
The FDA has extended its review of Mallinckrodt’s NDA for its investigational painkiller Xartemis XR by 90 days, saying it needs more time to review the drug’s proposed labeling. Read More
EU regulators on Friday assured Ariad that its leukemia drug and sole product Iclusig can continue to be sold throughout Europe for its approved indications. Read More
The FDA’s Office of New Drugs has notified Amarin that it is refusing to review the company’s appeal of the agency’s decision to rescind the SPA for the drugmaker’s ANCHOR study of its heart drug Vascepa. Read More
Drugmakers are pushing back on proposed EU GMP requirements that would expand safeguards against product cross-contamination, saying the proposed six-month timeline for implementation is unworkable. Read More
After assessing its response to a recall in April, Health Canada is considering requiring drugmakers to notify the agency about emerging risks of marketed drugs before initiating recalls. Read More