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Citing cost concerns, the UK’s healthcare watchdog is recommending against Celgene’s Otezla alone or in combination with disease-modifying antirheumatic drug therapies for adults with active psoriatic arthritis. Read More
The European Commission has approved Bristol-Myers Squibb’s Opdivo as both a first-line and second-line treatment for adults with advanced melanoma, allowing the drug to be marketed in all 28 member states. Read More
Concerned about high treatment costs, the UK’s healthcare cost watchdog wants Gilead Sciences to provide more information on its blockbuster leukemia drug Zydelig before it will consider recommending its use. Read More
The label the FDA issued for Hetlioz omitted “in blind patients without light perception,” thus allowing anyone with Non-24 disorder to use the drug. Read More
A federal judge says the FDA did not unlawfully decide to delay final approval of Veloxis Pharmaceuticals’ extended-release immunosuppression drug Envarsus. Read More
The Office of Pharmaceutical Quality’s “One Quality Voice” is “well on its way to becoming a reality,” CDER Director Janet Woodcock said Tuesday. Read More
The FDA issued final guidance today formally adopting the U.S. Pharmacopeia’s strict naming rules for drug containing salt-based active ingredients. Read More
The FDA has granted orphan drug designation to Berkeley, Calif., drugmaker Xoma’s investigational treatment for congenital hyperinsulinism, a life-threatening disease that causes the body to produce excessive amounts of insulin. Read More