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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
A judge dismissed claims that the FDA is precluded from approving generic versions of Otsuka’s blockbuster antipsychotic until its orphan exclusivity expires. Read More