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FDA approves J&J’s OPSYNVI for pulmonary arterial hypertension

Pharmaceutical Technology

The US FDA approved Johnson & Johnson's (J&J) OPSYNVI for chronic treatment in adult patients with pulmonary arterial hypertension.

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Xolair amplifies reach after FDA approval for treating food allergies 

Pharmaceutical Technology

Xolair is the first FDA-approved drug to reduce allergic reactions in people with one or more food allergies, as per Roche’s announcement.

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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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Iovance’s Amtagvi for melanoma treatment gains FDA approval

Pharmaceutical Technology

Iovance Biotherapeutics' Amtagvi has received accelerated US FDA approval for treating adults with metastatic or unresectable melanoma.

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FDA approves Ipsen’s Onivyde for pancreatic adenocarcinoma

Pharmaceutical Technology

Ipsen reported that the US FDA approved the Onivyde regimen (NALIRIFOX) as a first-line treatment for metastatic pancreatic cancer.

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Takeda’s EOHILIA receives FDA approval for EoE treatment

Pharmaceutical Technology

Takeda has received the US FDA approval for EOHILIA (budesonide oral suspension), an oral treatment for eosinophilic esophagitis (EoE).

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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.