Pharmaceutical Technology

JUNE 9, 2025

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.

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Pharmaceutical Technology

JUNE 10, 2025

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. Credit: MargJohnsonVA/Shutterstock.

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Pharmaceutical Technology

JUNE 20, 2025

Madrigal accessed a large US market when it won accelerated US Food and Drug Administration (FDA) approval in March 2024 for the first MASH treatment in the region. Rezdiffra is already available in the US for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis.

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Pharmaceutical Technology

JUNE 9, 2025

Aytu BioPharma has signed an exclusive agreement with Fabre-Kramer Pharmaceuticals to commercialise Exxua (gepirone) extended-release tablets, a new antidepressant, to the US market for major depressive disorder (MDD).

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Pharmaceutical Technology

JUNE 6, 2025

We are going to make this country the hub of biotechnology innovation,” RFK Jr said during a US Food and Drug Administration (FDA) roundtable on cell and gene therapy on 5 June. Those in attendance included cell and gene therapy experts, industry representatives, and US health agency chiefs.

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Pharmaceutical Technology

JUNE 20, 2025

The departure of the US Food and Drug Administration’s (FDA) cell and gene therapy director and deputy director fuels ongoing turbulence in the treatment modality’s sector and could lead to changes in safety monitoring for drugs, according to an investment analyst. Image credit: Tada Images via Shutterstock.

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Pharmaceutical Technology

JUNE 10, 2025

In a speech at the US Food & Drug Administration (FDA) in April, RFK Jr claimed that FDA employees were ‘sock puppets’ to the industry they regulate and made dubious claims about the existence of autism.

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