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The FDA has approved the first generic version of AstraZeneca’s Symbicort, a blockbuster drug-device combination product for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Read More
The FDA is asking its vaccines advisory committee to meet next month to make a recommendation on Pfizer’s and BioNTech’s March 15 request to amend its Emergency Use Authorization (EUA) for approval of a fourth shot/second booster of its COVID-19 vaccine Comirnaty for people age 65 and older. Read More
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