The company that developed the most expensive drug in the world knew about problems with its clinical data, but withheld that information from the FDA until after the drug had been approved, the agency said Tuesday. Nevertheless, the FDA said it's confident that the drug, Zolgensma, is still safe.

Between the lines: Zolgensma is a gene replacement therapy to treat spinal muscular atrophy in children younger than 2, manufactured by Novartis. It was approved in May and carries a $2.1 million price tag. In disclosing the faulty data submission, the FDA said it "will use its full authorities to take action, if appropriate, which may include civil or criminal penalties."

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4 hours ago - Health

Fauci says if people won't wear masks, maybe it should be mandated

Anthony Fauci. Photo: Graeme Jennings- Pool/Getty Images

NIAID director Anthony Fauci told CNN on Friday evening that if "people are not wearing masks, then maybe we should be mandating it."

Why it matters: Fauci made the comments the same day the U.S. hit its highest daily COVID-19 case count since the pandemic began.

Harris to Black voters: Casting a ballot is about honoring your ancestors

Democratic vice presidential nominee Kamala Harris speaks at a "Get Out The Vote" rally at Morehouse College. Photo: Elijah Nouvelage/AFP via Getty Images

Sen. Kamala Harris appealed to Black voters in Georgia on Friday, urging them to "honor the ancestors" by casting ballots, and again calling President Trump a "racist."

Why it matters: The U.S. saw a significant decline in African-American voter turnout between 2012 and 2016, reaching its lowest point since 2000. Higher turnout among Black Americans this year could tip the balance in favor of Democrats in key battleground states, including Georgia.

Updated 5 hours ago - Politics & Policy

Coronavirus dashboard

Illustration: Aïda Amer/Axios

  1. Politics: Fauci: Trump hasn't been to a COVID task force meeting in months.
  2. Sports: The youth sports exodus continues — Big Ten football is back.
  3. Health: U.S. hits highest daily COVID-19 case count since pandemic began —AstraZeneca to resume vaccine trial in U.S.How to help save 130,000 lives.
  4. Retail: Santa won't greet kids at Macy's this year.
  5. World: Spain and France exceed 1 million cases.