Devices & Diagnostics Letter

The Leaf received 510(k) clearance from the FDA in October 2019. Source: Devices & Diagnostics Letter

Genfit said it will now focus on developing the drug for the treatment of primary biliary cholangitis, a chronic liver disease. Source: Devices & Diagnostics Letter

Among other questions, the lawmakers asked what resources the agencies are using to assess the extent of the scams and what actions they are taking against those involved. Source: Devices & Diagnostics Letter

The FDA required a boxed warning for the drug because of its potential for misuse and abuse. Source: Devices & Diagnostics Letter

The drug was generally well tolerated, with no serious adverse events or deaths, the company said. Source: Devices & Diagnostics Letter

The vaccine generated a strong immune response in preclinical studies. Source: Devices & Diagnostics Letter

Gilead Sciences said it is buying a 49.9 percent stake in Tizona Therapeutics, a company developing first-in-class cancer immunotherapies, for $300 million in a transaction expected to close in the third quarter of this year. Source: Devices & Diagnostics Letter

Gilead Sciences has gotten approval from the FDA to launch a phase 1 trial of an inhaled version of its antiviral remdesivir for the earlier treatment of COVID-19 patients. Source: Devices & Diagnostics Letter

Faced with mounting evidence that hydroxychloroquine is ineffective in treating COVID-19, three trials of the drug have been terminated. Source: Devices & Diagnostics Letter

Ridgeback Biotherapeutics in July will launch two phase 2 trials of its investigational antiviral EIDD-2801 as a potential COVID-19 treatment. Source: Devices & Diagnostics Letter