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Upsher-Smith’s Qudexy XR is now available as a first-line monotherapy for children ages two and older who have partial-onset or tonic-clonic seizures. Read More
UCB’s Cimzia may soon be added to the list of arthritis drugs provided under England and Wales’ National Health Service, following a final draft recommendation by the UK’s healthcare cost watchdog. Read More
The FDA is clarifying its definition of “established conditions” to ensure drugmakers properly report postapproval chemistry, manufacturing and control changes in NDAs, ANDAs and BLAs. Read More
FDA approval of Pfizer subsidiary Wyeth’s Rapamune for lymphangioleiomyomatosis may be the light at the end of the tunnel for sufferers of the extremely rare lung disease. Read More
The FDA on Wednesday approved Patheon Pharmaceuticals’ Viberzi and Salix Pharmaceuticals’ Xifaxan for the treatment of irritable bowel syndrome with diarrhea in adult patients. Read More
A federal judge dealt Otsuka a blow, dismissing claims that the FDA is precluded from approving generic versions of its blockbuster antipsychotic Abilify until its orphan exclusivity runs out in December 2021. Read More