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FDA approves Sanofi and Regeneron’s Dupixent for bullous pemphigoid

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s Dupixent (dupilumab) as a treatment option for adults with bullous pemphigoid (BP), a condition that predominantly affects the elderly. Can pharma tariffs “Make America Manufacture Again”? Credit: Toa55/Shutterstock. Don’t let policy changes catch you off guard.

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MSD receives FDA approval for Enflonsia to prevent RSV

Pharmaceutical Technology

MSD has received US Food and Drug Administration (FDA) approval for Enflonsia (clesrovimab-cfor) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants. Can pharma tariffs “Make America Manufacture Again”? Credit: MargJohnsonVA/Shutterstock.

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Vutrisiran marks first silencer approved for ATTR-CM

Pharmaceutical Technology

Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.

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FDA approves YolTech’s YOLT-101 for familial hypercholesterolemia

Pharmaceutical Technology

YolTech Therapeutics has received the US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application for YOLT-101 to treat heterozygous familial hypercholesterolemia (HeFH). Can pharma tariffs “Make America Manufacture Again”? Credit: aipicte/Shutterstock. Don’t let policy changes catch you off guard.

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Tisento’s MELAS treatment receives fast track status from FDA

Pharmaceutical Technology

Tisento Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its investigational oral medicine, zagociguat, for mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes (MELAS), a rare mitochondrial disease. Can pharma tariffs “Make America Manufacture Again”?

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Mosanna Therapeutics gains $80m to advance OSA nasal spray

Pharmaceutical Technology

Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.

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EU’s Pharma Package falls short of Europe’s goal of global competitiveness

Pharmaceutical Technology

Experts praise the reforms to rare disease and antimicrobial research, but they worry that some provisions in the EU Pharma Package may harm innovation on the continent, contrary to its stated objectives. In a bid to chase competitiveness, the EU is advancing its most drastic revision of pharmaceutical law in 20 years.