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The FDA has shed light on how amendments to an NDA, BLA or supplement may affect review timelines established under the 2012 prescription drug user fee program. 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
Hospira has won a temporary restraining order blocking Mylan from marketing a generic version of its sedative Precedex, which the FDA authorized last week under the controversial section viii statement pathway that foregoes a patent challenge and instead allows manufacturers to “carve out” indications not protected by patents. Read More
Argentina recently agreed to open its borders to finished drug products from India, a policy change applauded by Indian manufacturers who now have access to the multi-billion-dollar market. Read More
Drugmaker ViiV Healthcare is set to launch its triple combination HIV therapy Triumeq in the U.S., after receiving a green light from the FDA. Read More
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