First-of-its-kind maintenance therapy approved for extensive-stage small cell lung cancer, a historically difficult-to-treat malignancy.
The designation for ALTO-101 targets cognitive impairment, a debilitating aspect of schizophrenia with no currently approved treatments.
The U.S. Food and Drug Administration has accepted for review the company's New Drug Application for Relacorilant, a treatment for Cushing's syndrome.
Key approvals for Regeneron, Corcept, and a Fast Track designation for Alto Neuroscience signal a positive regulatory environment.
Key approvals and fast-track designations for Insmed, Alto Neuroscience, and Corcept Therapeutics boost investor confidence in the industry's regulatory landscape.
Zepzelca, in combination with Roche's Tecentriq, is the first approved first-line maintenance therapy for extensive-stage small cell lung cancer.
ProSense cryoablation system gains marketing authorization as the first minimally invasive treatment for low-risk tumors in women over 70.
Regulators expedite review for ALTO-101, a novel treatment for cognitive impairment in schizophrenia, a condition with no currently approved therapies.