The FDA recently approved AstraZeneca’s Farxiga (dapagliflozin) for the treatment of heart failure with reduced ejection fraction (HFrEF) in adults with and without type 2 diabetes, marking the first time a drug in a class developed for diabetes was approved for heart failure even if diabetes is not present.
FDA alerts public not to use chloroquine and hydroxychloroquine to treat COVID-19, as they are not approved to treat anything other than malaria and auto immune disorders.
The agency takes other steps to make COVID-19 tests more available.
Companies cited over false coronavirus claims include The Jim Bakker Show.
Novel drugs, value-based contracting, biosimilars, and regulatory activity addressing costs will be among the hot button issues in the coming year.
Major depression drug recalled over wrong dosage.
The first FDA-approved to reduce functional abdominal pain in younger patients with irritable bowel syndrome is now available to medical providers.
The first respiratory biologic to be approved for administration via an autoinjector will be available in the US soon.
New indication joins a series of single-agent and combination treatments for various cancers.
How HHS efforts to increase competition could hurt patients.