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US FDA approves Bausch + Lomb and Novaliq’s DED treatment Miebo

Pharmaceutical Technology

It is the first and only prescription eye drop to receive FDA approval to treat DED that targets tear evaporation directly. Bausch + Lomb chairman and CEO Brent Saunders stated: “Today’s FDA approval of Miebo further advances DED treatment by addressing a significant unmet need for millions of people suffering with this disease.

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Janssen seeks FDA approval for lung cancer combination therapy

Pharmaceutical Technology

Janssen has sought US FDA approval for the Rybrevant combination regimen for locally advanced or metastatic non-small cell lung cancer.

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FDA approves Takeda’s targeted therapy for advanced colon cancer

Pharmaceutical Technology

On 8 November, Takeda announced it had received US Food and Drug Administration (FDA) approval for its oral Fruzaqla (fruquintinib) as a third-line treatment for adults with metastatic colorectal cancer (mCRC).

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Rystiggo receives FDA approval, strengthening UCB’s myasthenia gravis portfolio

Pharmaceutical Technology

UCB's Rystiggo has been granted FDA approval to treat myasthenia gravis in anti-AchR or anti-MuSK antibody-positive adults.

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Roctavian and BioMarin’s $2.9m haemophilia gene therapy secures FDA approval

Pharmaceutical Technology

BioMarin’s Roctavian, a one-time therapy for severe haemophilia A, has secured FDA approval following previous rejections and delays.

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Lilly challenges Wegovy dominance in weight loss market with FDA approval

Pharmaceutical Technology

Zepbound (tirzepatide) has been approved by the FDA approval and is expected to be launched in the US by the end of 2023.

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US FDA approves Reata Pharmaceuticals’ SKYCLARYS for Friedreich’s ataxia

Pharmaceutical Technology

“As a company, this is a transformative milestone highlighting our commitment to developing and commercialising novel therapies for patients with severe diseases with few or no approved therapies.” The post US FDA approves Reata Pharmaceuticals’ SKYCLARYS for Friedreich’s ataxia appeared first on Pharmaceutical Technology.