FDA & Biotech
9 hours ago

Alvotech Gains EU Agency Acceptance for Xolair Biosimilar

The marketing application for AVT23, a biosimilar to the multi-billion dollar asthma drug Xolair, marks a key regulatory step for Alvotech in the European market.

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FDA & Biotech
13 hours ago

Nyxoah Begins US Commercial Rollout of Genio Sleep Apnea Implant

First patients implanted with the novel neurostimulator marks a key step in challenging market leader Inspire Medical after recent FDA approval.

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FDA & Biotech
14 hours ago

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

The designation for ALTO-101 targets cognitive impairment, a debilitating condition with no currently approved treatments, signaling a major regulatory milestone.

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FDA & Biotech
20 hours ago

Zoetis Gains FDA Nod for First U.S. Screwworm Cattle Drug

Conditional approval for Dectomax-CA1 addresses a significant threat to the U.S. livestock industry, boosting company shares.

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Sector Analysis
21 hours ago

Semiconductor Sector Faces Headwinds on New US Export Curbs

Applied Materials forecasts a $600 million revenue hit, signaling broader disruption for the global chip industry amid escalating US-China tech tensions.

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FDA & Biotech
22 hours ago

Arvinas Shares Climb on Positive Phase 1 Parkinson's Drug Data

Early results for ARV-102, a novel PROTAC LRRK2 degrader, show the experimental therapy is well-tolerated and demonstrates key biomarker engagement.

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FDA & Biotech
23 hours ago

Roche Gains FDA Nod for First-in-Class Lung Cancer Therapy

Tecentriq and Zepzelca combination approved as first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC).

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FDA & Biotech
1 day ago

Novartis Gains FDA Approval for First-in-Class Oral Hives Drug Rhapsido

The approval of the twice-daily pill remibrutinib positions the company to challenge injectable treatments in a multi-billion dollar market.

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