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The FDA wants manufacturers to stop sending paper prescribing information to pharmacists and physicians who often don’t read it and only submit it electronically to the agency, a move that would create a single source for accurate labeling that would always be up to date. Read More
In their second reversal in a week, British healthcare cost monitors are now recommending Bayer’s prostate cancer drug Xofigo for men with hormone-relapsed prostate cancer and symptoms of bone metastases for whom docetaxel chemotherapy has failed. Read More
Teva’s first-filer rights to generic Celebrex are in doubt after a federal appeals court struck down a lower court’s decision upholding an FDA finding that the Israeli drugmaker was entitled to exclusivity on the blockbuster arthritis therapy. Read More
The FDA has approved Swiss drugmaker Novartis’ long-acting-release form of Signifor to treat the rare and life-threatening hormonal disorder acromegaly, following its approval in Europe last month. Read More
European regulators have selected nine applicants out of 29 manufacturers who submitted proposals to participate in the EMA’s adaptive pathway pilot project, which aims to speed drug approvals by authorizing products in stages for targeted populations. Read More
The FDA has unveiled the 14 members of its reconstituted Pharmacy Compounding Advisory Committee, a group that will play an influential role in deciding which products will be prohibited from compounding under a 2013 law. Read More
Janssen, GlaxoSmithKline and NewLink Genetics will be safe under a law that protects companies producing treatments to combat health emergencies. Read More
The U.S. Supreme Court declined to hear an appeal of a ruling that had struck down an Arizona law banning the use of the abortion drug RU-486 alongside misoprostol, a decision that effectively confirms earlier court positions upholding the FDA’s off-label drug use policy. Read More