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Botox maker Allergan is broadening its aesthetics portfolio with the $2.1 billion purchase of Kythera Biopharmaceuticals, a company that produces drugs to battle double chins and male-pattern baldness. 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 FDA expects to boost its China office staff to 35 within the next two years and its India staff to 23 as the agency focuses on increasing inspections in both countries. 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
Hoping to speed development of new treatments for children, the European Medicines Agency is offering drugmakers free meetings with members of its Paediatric Committee. 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The FDA is concerned that it takes too long to update the list of drugs withdrawn or removed due to safety or efficacy reasons and no longer acceptable for compounding, and is asking stakeholders to suggest alternatives to the advisory committee/rulemaking process. 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
Generics industry groups told FDA officials during a public meeting Monday that review times and approvals of generic drugs have slipped significantly since implementation of the Generic Drug User Fee Act, and they called for major changes when the program is reauthorized in fiscal 2018. Read More