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British inspectors turned up a laundry list of apparent violations at two Indian manufacturers, leading them to block drugs from one of them and impose restrictions on the other’s GMP certificate. Read More
Shortly after receiving an FDA warning letter for alleged major quality deficiencies, an Indian vaccine maker was slammed for data integrity issues and GMP violations by the World Health Organization. Read More
The European Medicines Agency is offering drugmakers new advice on when to update risk management plans for products with centralized marketing authorization. Read More
The FDA is spelling out the criteria for expanded access to investigational drugs in three final guidances to make the process as clear as possible. Read More
Despite a surge in new oncology therapies in the past five years, a new report says that access to many of these drugs is limited to only a handful of countries. Read More
The FDA could be increasing its recommendation on the amount of proposed suffixes — from three to 10 — that biosimilars applicants can propose for their products. 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