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Sponsors developing therapies for rare pediatric diseases must pay the FDA roughly $2.6 million to use a priority review voucher in the new fiscal year that starts today. Read More
Impax has agreed to pay shareholders $8 million to end a class action lawsuit alleging the brand and generics maker deliberately withheld the extent of its manufacturing practice violation problems. Read More
FDA investigators and their European counterparts are comparing training and auditing procedures as the first steps in a new push to increase mutual reliance on each other’s inspections. Read More
Regulators in Japan have proposed changes to the standards for using biological ingredients during the manufacture of pharmaceuticals, quasi-drugs and medical devices. Read More
Alimera Sciences has won FDA approval of its eye drug Iluvien after several years of negotiations with the agency to address potential safety concerns. Read More
The FDA is requiring new cardiac and cerebral warnings for Genentech’s asthma drug Xolair, based on an evaluation of long-term safety data, but the agency stopped short of mandating the strictest black box warning. Read More
A federal judge has tossed out some conspiracy claims brought against Abbott and its spinoff AbbVie over an alleged coupon scheme to boost sales of their branded arthritis drug Humira and testosterone therapy AndroGel. Read More
Actavis said it will continue marketing the original formulation of its blockbuster Alzheimer’s drug Namenda for 60 days longer than originally planned, as the drugmaker faces antitrust allegations over its plans to withdraw the product in favor of a newer version. Read More