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The FDA has handed Mylan and Fujifilm Kyowa Kirin Biologics approval for their biosimilar of Humira (adalimumab), marking the agency’s sixth approval for a biosimilar of AbbVie’s blockbuster immunosuppressive drug. Read More
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