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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
The FDA has approved Regeneron Pharmaceuticals’ Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn), a combination of three monoclonal antibodies, making it the agency’s first approved treatment for the Ebola virus. Read More
Fewer than a third of new drugs approved by the FDA and the European Medicines Agency over the past decade had high therapeutic value, a team of U.S. and Swiss researchers found. Read More
The FDA said the drug could lead to opioid “stacking,” as patients will need an additional opioid following treatment, increasing the risk of adverse effects. Read More