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The FDA has for a third time rejected Janssen and Bayer’s push to have their blockbuster blood-thinner Xarelto approved to treat patients with acute coronary syndrome (ACS). Read More
A drug to treat a rare congenital enzyme disorder developed by BioMarin Pharmaceutical became the first product approved by the FDA under its rare pediatric disease priority review voucher program. Read More
The FDA is investigating whether it is requiring drugmakers to present too much risk information in direct-to-consumer (DTC) television ads, which could lead to a potentially drastic departure from current marketing regulation. Read More
In the wake of a rash of infant deaths related to GMP-certified hepatitis B vaccines, China is renewing its push to have makers of vaccines, blood products and sterile injectables obtain a revised good manufacturing practice certificate. Read More
Active pharmaceutical ingredient (API) manufacturers operating in Canada must establish clearly defined and controlled manufacturing processes to ensure consistency under Health Canada’s newly finalized good manufacturing practices (GMP) guidelines. Read More
The FDA and Indian Ministry of Health & Family Welfare will begin sharing information from quality inspections of drugmakers’ manufacturing facilities. Read More
Indian officials are contemplating stripping a number of drugs of their exclusivity periods, clearing the way for companies to produce knock-off products that will bring down costs. Read More
Sponsors of new drugs seeking marketing authorization in the EU must now apply to receive a numerical code unique to the application, the European Medicines Agency (EMA) said Tuesday. Read More