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EMA is proposing a broader scope for guidelines on initial human trials to address emergent practices and safety issues linked to participant deaths. Read More
British authorities are ordering an Indian manufacturer to recall batches of progesterone injections after an inspection turned up one critical GMP violation and three major ones at one of its facilities. Read More
The European Medicines Agency recommendations for drug approvals saw a steady uptick in 2015, even as the number of new active substances fell slightly. Read More
The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. Read More
BioMarin is calling it quits for its Duchenne muscular dystrophy candidate and three related products in its pipeline after the EMA’s Committee for Medicinal Products for Human Use signaled that it would not back the candidate. Read More
An Indian court is ordering Pfizer to honor an earlier promise to dump large quantities of its steroid Medrol prior to the drug’s expiration date. Read More
Italian regulatory authorities have cited two Indian drugmakers for dozens of GMP issues, ranging from data security to quality management issues. Read More
The UK’s National Institute for Health and Care Excellence refused to recommend Janssen’s chronic lymphocytic leukemia treatment Imbruvica for reimbursement in June, but left the door open to further discussion. Read More
While retail prices for cancer drugs may be the highest in the U.S., these medicines appear to be less affordable in poorer countries such as India and China despite their lower prices, according to a study. Read More