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Brazil's Anvisa issued a rule on June 18 establishing criteria for the priority review of small molecule drugs and biologics. Rule No. 37 applies to marketing authorization, postauthorization and clinical study applications. Read More
European regulators warn that the lactation-control drug bromocriptine should only be used for compelling medical reasons, and should not be used routinely for preventing or stopping milk production after childbirth. Read More
The FDA has cleared GlaxoSmithKline’s asthma drug Arnuity, adding a fourth product to GSK’s growing portfolio of respiratory drugs administered through its dry-powder inhaler Ellipta. Read More
In an about face, a UK healthcare cost watchdog is now recommending coverage of Celgene’s blockbuster cancer drug Revlimid, persuaded by the drugmaker’s proposed payment scheme. Read More
Ferring Pharmaceuticals has won its appeal of a UK cost effectiveness watchdog’s final recommendation that would have drastically reduced the intended patient population for its cancer treatment Firmagon. Read More
Sanofi unit Genzyme says it plans to launch its new Gaucher disease therapy Cerdelga in the U.S. next month after receiving FDA approval late Tuesday. Read More
In an unusual case, Novo Nordisk agreed this week to pay $89,315 to Danish authorities to settle allegations it didn’t disclose the FDA’s rejection of two insulin products fast enough. Read More
Eli Lilly and Boehringer Ingelheim have won tentative FDA approval for their insulin product Basaglar, which is considered the biosimilar of a Sanofi product in Europe but is being reviewed as its own NDA in the United States. Read More