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Following an inspection of its Chantilly, Va., plant, the FDA cited Nutravail for failing to ensure data integrity at the facility or to validate reports from a component supplier. Read More
The Government Accountability Office (GAO) on Monday agreed to begin looking into allegations that the Trump administration exerted political pressure on the FDA and Centers for Disease Control and Prevention (CDC) to influence pandemic-related policies, following a request by three Democrat senators. 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
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