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The UK’s healthcare costs regulator Tuesday launched the Office of Market Access, providing drugmakers with a dedicated team to address queries about cost-benefit assessments. Read More
The FDA is seeking feedback on the chemistry, manufacturing and controls information that it wants drugmakers to include in INDs for gene therapies containing microbial vectors. Read More
The European Medicines Agency’s decision to redact certain personal and commercial information from clinical study reports before releasing them to a private citizen did not violate EU transparency policy, the European ombudsman says. Read More
European regulators have granted accelerated assessment for GlaxoSmithKline’s antiseptic chlorhexidine gel for the prevention of umbilical cord infections. Read More
The FDA hit another Indian active pharmaceutical ingredients maker with a warning letter after an inspection revealed data integrity issues and significant cGMP violations. Read More
Roseville, Minn.-based Rebiotix has been granted FDA breakthrough therapy status for its lead product RBX2660 to treat recurrent Clostridium difficile infection. Read More