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FDA approves twice-yearly shot of Gilead drug for HIV prevention

Bio Pharma Dive

The clearance ushers in a closely-watched launch for Gilead, which aims to show a long-acting injection can upend a market dominated by oral medicines.

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Novavax seeks FDA approval for updated Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought US FDA approval for an updated JN.1 1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

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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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FDA approves Johnson & Johnson’s Tremfya to treat Crohn’s disease

Pharmaceutical Technology

J&J has received US FDA approval for Tremfya (guselkumab), to treat moderately to severely active Crohn's disease (CD) in adults.

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FDA approves Ascendis Pharma’s YORVIPATH for hypoparathyroidism

Pharmaceutical Technology

Ascendis Pharma has obtained US Food and Drug Administration (FDA) approval for its YORVIPATH to treat hypoparathyroidism in adults.

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WestGene wins FDA approval for mRNA vaccine to treat certain cancers

Pharmaceutical Technology

The FDA approved WestGene’s mRNA therapeutic cancer vaccine as mRNA cancer vaccine development rises in popularity.

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Celltrion’s Avtozma Receives FDA Approval, Making it the Third Actemra Biosimilar to Hit the Market

XTalks

Celltrions Actemra (tocilizumab) biosimilar Avtozma (tocilizumab-anoh) has received FDA approval for multiple indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) as well as COVID-19.