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RegeneRx Biopharmaceuticals’ dry eye candidate RGN-259 missed its primary endpoints in a Phase 2/3 trial, failing to show statistically significant improvements in either total ocular discomfort or total corneal fluorescein staining. Read More
Clovis Oncology is stopping development of the lung cancer candidate rociletinib after the FDA warned the company of a potential complete response letter. Read More
Four Senate GOP HELP committee members have penned a letter to FDA Commissioner Robert Califf complaining about the agency’s handling of draft guidances. Read More
FDA Commissioner Robert Califf made a forceful call for “adequate” funding from Congress to implement pending biomedical innovation legislation. Read More
Oeyama-Moto is back in the hot seat after the agency accused the company of violating a clinical hold the agency had placed on a clinical trial. Read More
Companies developing direct-acting antiviral hepatitis C drugs should factor in interferon treatment when designing clinical trials, the FDA said Tuesday. Read More