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FDA removes safety programme for CAR-T therapies to boost uptake

Pharmaceutical Technology

The agency said that safety information can be adequately conveyed using drug product labelling. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. How will RFK Jr’s American dream for vaccines play out? This includes a boxed warning for the risks of CRS and neurological toxicities.

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GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients

Pharmaceutical Technology

Robert Barrie July 14, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Broader label coverages for Pfizer and Moderna’s vaccines mean they have made in-roads into GSK’s RSV dominant market share. Give your business an edge with our leading industry insights.

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Sarepta halts Elevidys shipments following FDA pressure

Pharmaceutical Technology

It is important for the patients we serve that Sarepta maintains a productive and positive working relationship with FDA, and it became obvious that maintaining that productive working relationship required this temporary suspension while we address any questions that FDA may have and complete the Elevidys label supplement process.”

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Sarepta and Roche halt DMD gene therapy’s use after second death  

Pharmaceutical Technology

By GlobalData Learn more about Strategic Intelligence Corwin added that Elevidys’s label will likely be updated to reflect the risk of ALF. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

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From data to impact: How real-world evidence will transform healthcare

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Skip to main content Monday 7 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

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Sarepta Therapeutics to cut 500 jobs amid restructuring

Pharmaceutical Technology

July 17, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The announcement included updates on Elevidys’ label changes for Duchenne muscular dystrophy treatment. It also announced an update regarding its Elevidys label changes for Duchenne muscular dystrophy (DMD) treatment. Credit: luchschenF/Shutterstock.com.

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Moderna’s mRNA RSV vaccine wins expanded FDA approval for younger adults

Pharmaceutical Technology

Vaccines under political pressure Whilst the label expansion reflects an easing in regulatory tension surrounding mRNA vaccines under the Trump administration, FDA approval does not automatically mean shots enter national immunisation schedules. It also gained FDA approval a year before mRESVIA, giving it first to market advantage.