FDA & Biotech
11 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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Earnings
14 hours ago

Constellation Brands Earnings to Test Consumer Spending Appetite

Investors are closely watching the beverage giant's Q3 results on Monday for insights into the health of the alcoholic beverage market.

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FDA & Biotech
14 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
16 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
22 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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FDA & Biotech
1 day 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
1 day 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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