We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Sanofi and Regeneron’s biweekly injectable Praluent effectively lowers bad LDL cholesterol and has few side effects, the FDA says in briefing materials released ahead of a Tuesday advisory committee meeting. Read More
The UK’s National Institute for Health and Care Excellence issued draft guidance Friday on two prostate cancer drugs, recommending Bayer’s Xofigo while declining to endorse Ferring Pharmaceuticals’ Firmagon. Read More
The FDA is clarifying what postapproval chemistry, manufacturing and control changes drugmakers need to report to NDAs, ANDAs and BLAs — with the aim of spurring more flexible regulatory pathways for such changes. Read More
Members of the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18-6 Thursday to recommend approval of Sprout’s female sexual dysfunction drug, despite lingering safety concerns. Read More
The UK’s healthcare cost regulator is asking BioMarin to provide more information on Vimizim, its treatment for the rare inherited disease Morquio A Syndrome, saying current evidence doesn’t support coverage of the drug. Read More
The UK’s healthcare cost authority has reversed itself and is recommending Boehringer Ingelheim’s Vargatef in combination with docetaxel for previously treated, locally advanced metastatic or locally recurrent non-small cell lung adenocarcinoma. Read More