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The FDA has sent AstraZeneca a Complete Response Letter (CRL) over its supplemental Biologics License Application (sBLA) for the company’s blockbuster Fasenra (benralizumab), as a treatment for chronic rhinosinusitis with nasal polyps (CRSwNP). Read More
In the late-stage study, Jardiance was shown to reduce relative risk of heart failure-related death or hospitalization by 21 percent vs. placebo. Read More
The FDA has approved GlaxoSmithKline’s blockbuster cancer drug Opdivo (nivolumab) in combination with chemotherapy for adult patients with resectable nonsmall-cell lung cancer (NSCLC). It is the first approved neoadjuvant treatment for patients with early-stage NSCLC. Read More
The FDA has issued a complete response letter (CRL) to Reata Pharmaceuticals, rejecting the company’s new drug application (NDA) for bardoxolone methyl for treatment of patients with Alport syndrome-related chronic kidney disease. Read More
Amryt Pharma received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Oleogel-S10 for treating a rare genetic skin ailment — epidermolysis bullosa (EB). Read More
The antibody therapy received emergency authorization in December for treating immunocompromised people 12 years and older who may be unable to mount a proper immune response to a COVID-19 vaccine. Read More