Permanent J-Code from CMS aims to streamline reimbursement and broaden patient access for its graft-versus-host disease treatment.
Analyst confidence swells following positive FDA alignment on the company's pivotal gene therapy trial for Rett Syndrome.
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.
Regulators express significant doubts over the company's lead drug candidate, avacopan, sparking a massive investor sell-off.
The new oral treatment addresses chronic spontaneous urticaria in patients unresponsive to antihistamines, driving shares up over 2.7%.
Company receives a Complete Response Letter for its Menkes disease treatment, CUTX-101, citing manufacturing issues, not safety or efficacy concerns.
Designation aims to speed development of novel tau-targeting antibody for early-stage Alzheimer's disease.
Conditional approval for screwworm treatment Dectomax-CA1 opens a new revenue stream and addresses a key industry need, boosting investor confidence.