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FDA To Review Teva and Alvotech Drug That Could Compete With Regeneron's Eylea

Key Takeaways Teva Pharmaceutical Industries and partner Alvotech said the Food and Drug Administration agreed to review their AVTO6 treatment for eye disorders. The treatment is a biosimilar that could compete with Regeneron Pharmaceuticals’ Eylea.

Managed Healthcare Executive · 12h

FDA Accepts Alvotech/Teva’s Application for Eylea Biosimilar

So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval for its biosimilar to be completed in the fourth quarter of 2025.

Business Insider · 17h

Alvotech and Teva’s BLA filing for AVT06 accepted by FDA

Alvotech (ALVO) and Teva Pharmaceuticals (TEVA) announced that the FDA has accepted for review a Biologics License Application, or BLA, for

Hosted on MSN · 12h

Teva and Alvotech gets FDA review acceptance for its proposed biosimilar to Eylea

Alvotech (NASDAQ:ALVO) and Teva Pharmaceuticals (NYSE:TEVA) said on Tuesday that the U.S. FDA has accepted for review a Biologics License Application for a biosimilar targeting Regeneron’s (REGN) blockbuster eye disease therapy,

Regeneron Gets Appeals Court to Impose Tougher Kickback Standard

Regeneron Pharmaceuticals Inc. convinced the First Circuit to impose a higher causation standard in the government’s False Claims Act case alleging a drug kickback scheme, according to a Tuesday ...

Why Regeneron's Price May Soon Break Out

Regeneron Pharmaceuticals' fourth quarter results beat my and Wall Street analysts' expectations. See why REGN stock is a top ...

BioSpace14d

Regeneron Misses on Eylea, Dupixent Sales; Issues First-Ever Dividends

Despite lackluster sales of Eylea’s high-dose formulation and Sanofi-partnered Dupixent, Regeneron beat Q4 forecasts overall ...

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Regeneron’s earnings boosted by more than doubling of U.S. sales of blockbuster eye drug Eylea

Regeneron Pharmaceuticals Inc.’s stock rose 4.9% Tuesday to put it on track for its biggest one-day gain in almost two years, ...

REGN INVESTOR ALERT: Bronstein, Gewirtz and Grossman, LLC Reminds Investors of Regeneron Pharmaceuticals, Inc. to Contact the Firm Today!

NEW YORK CITY, NY / ACCESS Newswire / February 17, 2025 / Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law ...

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Regeneron beats quarterly estimates on eczema drug demand; launches dividend program

Regeneron Pharmaceuticals beat fourth-quarter sales and profit estimates on Tuesday, on continuing demand for its eczema ...

modernretina8d

Regeneron reveals positive results from multiple trials evaluating Eylea HD (aflibercept) injection 8 mg

Regeneron Pharmaceuticals has announced results from the phase 3 QUASAR trial and its extension study of the phase 3 PULSAR ...

Nasdaq10d

Regeneron Reports Positive Three-Year Results for EYLEA HD Treatment in Wet Age-Related Macular Degeneration

Regeneron Pharmaceuticals announced positive three-year results from an extension study of EYLEA HD (aflibercept) Injection 8 mg for treating wet age-related macular degeneration (wAMD).

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