FDA & Biotech
2 hours ago

Roche's Tecentriq Combo Wins Key FDA Nod for Lung Cancer

First-of-its-kind maintenance therapy approved for extensive-stage small cell lung cancer, a historically difficult-to-treat malignancy.

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FDA & Biotech
5 hours ago

Alto Neuroscience Stock Jumps on FDA Fast Track for Schizophrenia Drug

The designation for ALTO-101 targets cognitive impairment, a debilitating aspect of schizophrenia with no currently approved treatments.

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FDA & Biotech
9 hours ago

Corcept Shares Jump 5% as FDA Accepts Drug Application

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.

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FDA & Biotech
12 hours ago

Biotech Sector Jumps on Trio of Favorable FDA Rulings

Key approvals for Regeneron, Corcept, and a Fast Track designation for Alto Neuroscience signal a positive regulatory environment.

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Technology
1 day ago

Fujitsu Shares Climb on Expanded NVIDIA AI Collaboration

The partnership aims to co-develop full-stack AI infrastructure, targeting enterprise and industrial use cases in Japan and beyond.

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FDA & Biotech
1 day ago

IceCure Medical Soars on FDA Nod for Breast Cancer Device

ProSense cryoablation system gains marketing authorization as the first minimally invasive treatment for low-risk tumors in women over 70.

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FDA & Biotech
1 day ago

Jazz Pharma Stock Jumps on FDA Approval for Lung Cancer Drug

Zepzelca, in combination with Roche's Tecentriq, is the first approved first-line maintenance therapy for extensive-stage small cell lung cancer.

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FDA & Biotech
1 day ago

Alto Neuroscience Soars 56% on FDA Fast Track for Schizophrenia Drug

Regulators expedite review for ALTO-101, a novel treatment for cognitive impairment in schizophrenia, a condition with no currently approved therapies.

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