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Tisento’s MELAS treatment receives fast track status from FDA

Pharmaceutical Technology

Subjects who conclude the trial will be qualified for an open-label extension trial. Can pharma tariffs “Make America Manufacture Again”? All subjects will be given zagociguat in one of the 12-week durations and a placebo during the other. Give your business an edge with our leading industry insights.

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How to conduct GMP training for employee

GMPSOP

GMP/GLP and PPE training are applied to all employees, contractors and casual staff working in a GMP environment, including manufacturing, packaging, labelling, distribution, QA, QC, development, validation, engineering, IT staff and anyone whose activities could affect product quality. </p>

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FDA approves label expansion of AbbVie hepatitis C therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved the label expansion of AbbVie’s Mavyret (glecaprevir/pibrentasvir) for treating adults and paediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection. Can pharma tariffs “Make America Manufacture Again”? Credit: © AbbVie Inc. All rights reserved.

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EHA 2025: AstraZeneca’s surovatamig is potential next-gen BiTE for R/R B-ALL

Pharmaceutical Technology

At the 2025 Congress of the European Hematology Association (EHA 2025), held from 12 June 12 to 15 June in Milan, Italy, preliminary dose-escalation and optimisation results from the global, multicentre, open-label, single-arm Phase I/II SYRUS clinical trial (NCT06137118) were presented on the second day.

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Twenty Women Leaders In Healthcare Industry

PharmaShots

Other Affiliations: Angela is an active Board of Director member of the Pfizer Foundation (a charitable organization addressing global health challenges), European Federation of Pharmaceutical Industries and Associations (EFPIA), and UPS (the global leader in package delivery and supply chain logistics). LinkedIn Total experience: 16 yrs.

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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. Can pharma tariffs “Make America Manufacture Again”? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

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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. Can pharma tariffs “Make America Manufacture Again”?