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The approval was granted under Project Orbis, which enables concurrent reviews by the FDA and health authorities of Australia, Canada and Singapore. Read More
Roche and AbbVie have won FDA approval of Venclexta (venetoclax) in combination with the chemotherapy drugs azacytidine, decitabine or low-dose cytarabine for the treatment of acute myeloid leukemia in adults aged 75 or older, or those unable to undergo intensive chemotherapy. Read More
Fujifilm has filed for approval of its influenza drug Avigan (favipiravir) in Japan for treatment of COVID-19 patients, after the antiviral showed promise in a phase 3 trial. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended ten medicines for authorization by the European agency, including two investigational cell therapies and two antiretrovirals. Read More