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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. In February 2025, the FDA accepted Dupixent’s supplemental biologics licence application (sBLA) for priority review.

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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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Pharmacist to Clinical Strategy Leader: Brendan Doran on Building a Career in Biotech

The Nontraditional Pharmacist

What are the regulatory constructs that the FDA puts out in front of you to get there? And then how do you develop documents to basically get approval from the FDA to study your drug in humans? There’s a lot of other aspects that go along with it, but at a high level that’s roughly what that was.

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Vutrisiran marks first silencer approved for ATTR-CM

Pharmaceutical Technology

Give your business an edge with our leading industry insights. 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). Credit: aipicte/Shutterstock. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

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Hypertension: A Silent Killer Requiring Novel Therapies

Pharmacy Times

A new drug application for lorundrostat is expected to be filed with the FDA in 2025. doi:10.1016/20S0140-6736(22)02034-7 Aprocitentan (Tryvio) package insert. Widaplik (telmisartan, amlodipine, indapamide) package insert. Jansen, PharmD Candidate , Mark A. mg/d, 1 mg/d, 2 mg/d, and placebo for 12 weeks. mmHg (p = 0.003) and 11.0

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FDA Approves Immunoglobulin Formulation With Low IgA Content for Primary Immunodeficiency

Pharmacy Times

Takeda has informed the FDA that the manufacturing of Gammagard S/D will cease in December 2027. The new formulation is contraindicated in patients with severe hypersensitivity to immunoglobulin products, requiring careful monitoring.

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