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Two device companies that share the same address in Natick, Mass., have received separate warning letters from the FDA for quality system failures observed during an FDA inspection, including not fully investigating complaints and a lack of adequate corrective and preventive actions (CAPA). Read More
A federal court in Kansas has ruled that a class action antitrust lawsuit against Mylan over marketing and distribution of its EpiPen can go forward. Read More
The FDA is reviewing a Biologics License Application (BLA) for an innovative, first-in-class treatment for potentially fatal Clostridium difficile infections — an enema-delivered human stool transplant. Read More
Nebulized ensifentrine, an investigational inhaled anti-inflammatory, reduced exacerbations of chronic obstructive pulmonary disease (COPD) by 42 percent over 24 weeks — a significant benefit that could propel Verona Pharma to submit regulatory documents for a first-in-class treatment. Read More