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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
Catalyst Pharmaceuticals has filed a patent infringement lawsuit against competitor Jacobus Pharmaceutical over the latter’s Ruzurgi (amifampridine) tablets. Read More
AMAG Pharmaceuticals is refusing to withdraw its controversial preterm injection drug Makena from the market and has requested a public hearing with the FDA hoping to reverse the agency’s call for the drug’s withdrawal. 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 National Institutes of Health (NIH) is starting a late-stage trial of two existing drugs and one investigational agent to assess their potential to control cytokine storm, an immune system overreaction in COVID-19 patients. Read More
HHS Deputy Chief of Staff for Policy Paul Mango said that within 24 to 48 hours after an Emergency Use Authorization is granted for a COVID-19 vaccine, “we expect to be putting needles in people’s arms.” Read More
Pfizer will not be ready to submit an Emergency Use Authorization (EUA) application for its COVID-19 vaccine candidate until late in November, CEO Albert Bourla has announced, despite his previous projections of possibly filing for an EUA this month. Read More
Gilead Sciences has rejected early findings from the World Health Organization’s Solidarity trial showing four antivirals, including remdesivir, had “little or no effect” on hospitalized COVID-19 patients, criticizing the trial’s design and expressing concern that the data hadn’t gone through a peer review. Read More