Gene therapy candidate TSHA-102 for Rett syndrome receives key designation, paving the way for an accelerated regulatory pathway.
The company outlined key milestones for its sublingual drug delivery platform, including a planned 2025 FDA submission for its high-dose aspirin.
Zepzelca combo becomes first approved maintenance treatment for extensive-stage small cell lung cancer, a historically difficult-to-treat disease.
The approval marks a new standard for first-line maintenance treatment in extensive-stage small cell lung cancer, a historically challenging disease.
Analyst confidence swells following positive FDA alignment on the company's pivotal gene therapy trial for Rett Syndrome.
Permanent J-Code from CMS aims to streamline reimbursement and broaden patient access for its graft-versus-host disease treatment.
Hardware manufacturer Canaan's landmark U.S. order and Cipher Mining's strategic AI partnerships fuel renewed investor confidence.
Genentech's Tecentriq combination therapy is the first maintenance treatment for extensive-stage small cell lung cancer, a significant advance in a hard-to-treat disease.