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Nabriva Therapeutics drew a second complete response letter (CRL) from the FDA for its injected antibiotic Contepo (fosfomycin), but said the problem was not related to the drug’s safety or efficacy. Read More
Patients treated with Keytruda demonstrated a progression-free survival of 16.5 months compared to 8.2 months for those who received chemotherapy. Read More
The FDA issued Intercept Pharmaceuticals a complete response letter for its investigational drug, obeticholic acid (OCA), for liver fibrosis due to nonalcoholic steatohepatitis (NASH). Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended eight drugs for approval, including Vertex Pharmaceuticals’ triple combination therapy for treatment of cystic fibrosis. Read More
The FDA hit AbbVie with a complete response letter (CRL) for abicipar pegol, its investigational drug for treatment of wet age-related macular degeneration. Read More
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