BioPharma Dive April 4, 2024
Kristin Jensen

After years of ups and downs, Swiss drugmaker Basilea has broken into the U.S. market with its drug Zevtera, but is still searching for a partner.

Dive Brief:

  • Swiss drugmaker Basilea Pharmaceutica on Wednesday won Food and Drug Administration approval for its drug Zevtera in a step that could help address the critical need for new antibiotics in the U.S.
  • The FDA cleared the drug for three different conditions: community-acquired bacterial pneumonia, Staphylococcus aureus bloodstream infections, and acute bacterial skin and skin structure infections. The approval covers adults with any of the three conditions as well as pediatric patients with pneumonia.
  • Basilea plans to announce a commercial partner for the U.S. market “around mid-year” and said interest increased as...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

Continue Reading

 
Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
Related Articles:
FDA warns GLP-1 compounder over safety rules
GLP-1 drug approvals: A breakdown
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
FDA approves Novo Nordisk's Ozempic to treat chronic kidney disease in those with diabetes, expanding its use
Certainty vs. speed: How do patients feel about the tradeoff for new cancer drugs?

Share This Article