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The FDA on Friday approved Wellstat Therapeutics’s Xuriden to treat a rare metabolic disorder known as hereditary orotic aciduria, landing the company a rare pediatric disease priority review voucher. Read More
Yet another Indian drugmaker has been dinged for serious data integrity and GMP issues — this time during a June 4 to 7 inspection by the World Health Organization. Read More
GlaxoSmithKline is recalling more than 427,000 tubes of mupirocin calcium 2% creams and ointments in various sizes due to penicillin cross contamination and the presence of particulates. Read More
The FDA has granted breakthrough therapy designation to Roche’s investigational ACE910 for the prophylactic treatment of patients 12 years and older with hemophilia A with factor VIII inhibitors. Read More
The FDA has delayed by three months its decision on Alexion Pharmaceuticals‘s metabolic disorder drug Kanuma to review new chemical manufacturing and controls information. Read More
The European Commission has approved Novartis’ Farydak as the first histone deacetylase inhibitor for treatment of multiple myeloma available in the EU. Read More
Beleaguered Indian companies continue to stumble when it comes to quality issues, with generics maker Wockhardt conducting yet another recall, and active pharmaceutical ingredients makers Mahendra Chemicals and Nosch Labs racking up GMP deficiencies. Read More
The FDA has identified 10 quality data points that finished dosage form and active pharmaceutical ingredient makers will need to collect to calculate four quality metrics for each product they produce. Read More