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Madrigal wins FDA approval of first drug for MASH

Bio Pharma Dive

But its sales potential is unclear, and competition could emerge from popular weight loss drugs. Rezdiffra’s clearance is a turning point in the fight against the liver disease.

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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 Shorla’s oncology drug for T-cell leukaemia

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Shorla Oncology’s Nelarabine Injection, an oncology drug, to treat T-cell leukaemia, an aggressive blood and bone marrow cancer that progresses quickly. The company develops innovative oncology drugs with a focus on paediatric and orphan cancers.

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FDA Approves New Alzheimer’s Drug Designed to Slow Cognitive Decline

AuroBlog - Aurous Healthcare Clinical Trials blog

The US Food and Drug Administration (FDA) on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer’s disease.

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MSD leaps on FDA approval of PAH drug sotatercept

pharmaphorum

MSD’s Winrevair (sotatercept) has become the first FDA-approved therapy for PAH that addresses the underlying mechanism behind the disease rather than its symptoms

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

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). It is the first and only prescription eye drop to receive FDA approval to treat DED that targets tear evaporation directly.

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FDA approves Merck lung disease drug acquired in $11B deal

Bio Pharma Dive

Merck is couting on Winrevair, which it acquired by buying Acceleron Pharma, to help soften the blow when Keytruda loses patent protection later this decade.