Pharmaceutical Technology

JULY 8, 2025

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Pharmaceutical Technology

JUNE 30, 2025

Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. How will RFK Jr’s American dream for vaccines play out?

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Pharmaceutical Technology

JULY 15, 2025

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Pharmaceutical Technology

JULY 15, 2025

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Pharmaceutical Technology

JUNE 6, 2025

Originally approved for children in 2021, the FDA updated the drug’s label in January this year to include adults. Can pharma tariffs “Make America Manufacture Again”? The mechanism of action of Qelbree, though unclear, is thought to be through inhibiting the reuptake of norepinephrine.

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Pharmaceutical Technology

JUNE 30, 2025

The agency said that safety information can be adequately conveyed using drug product labelling. We may still continue to send you service-related and other non-promotional communications. 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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Pharmaceutical Technology

JULY 14, 2025

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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Pharmaceutical Technology

JUNE 30, 2025

How will RFK Jr’s American dream for vaccines play out? Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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Pharmaceutical Technology

JUNE 30, 2025

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Pharmaceutical Technology

JULY 17, 2025

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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Pharmaceutical Technology

JULY 11, 2025

With a comprehensive EU label spanning lung and gastrointestinal cancers, and more than 100 regulatory approvals globally, we are delivering on our ambition to bring innovative therapies to more patients around the world.” Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JULY 15, 2025

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Pharmaceutical Technology

JULY 15, 2025

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Pharmaceutical Technology

JULY 7, 2025

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Pharmaceutical Technology

JULY 4, 2025

Its European label covers a range of cancers, including lung, biliary tract, and liver, amongst others. AstraZeneca is also eying up label expansions for Imfinzi in non-muscle invasive bladder cancer (NMIBC), a larger market given that 70% of new bladder cancer diagnoses come from this segment.

Chemotherapy 52

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Pharmaceutical Technology

JUNE 13, 2025

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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Pharmaceutical Technology

JUNE 16, 2025

By GlobalData Learn more about Strategic Intelligence Corwin added that Elevidys’s label will likely be updated to reflect the risk of ALF. We may still continue to send you service-related and other non-promotional communications. Can pharma tariffs “Make America Manufacture Again”? Don’t let policy changes catch you off guard.

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Pharmaceutical Technology

JUNE 13, 2025

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”?

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pharmaphorum

JULY 7, 2025

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued clear guidance for incorporating RWE in regulatory submissions, labelling expansions, and post-market monitoring. Previously, she held multiple leadership roles at Forrester, including VP and research director, and VP principal analyst.

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Pharmaceutical Technology

JULY 8, 2025

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pharmaphorum

JULY 2, 2025

Explainability is also crucial, particularly for areas of drug development, where AI outputs must be effectively communicated to meet regulatory requirements and build trust among clinicians, regulators, and patients. AI technologies can enable companies to program, rather than write, submissions to health authorities.

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Pharmaceutical Technology

JULY 10, 2025

By GlobalData Learn more about Strategic Intelligence While success in these indications is putting value on label expansions in earlier lines of therapies, Kolesnikova noted that there are various disadvantages to CAR T therapies. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

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Pharmaceutical Technology

JUNE 16, 2025

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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Pharmaceutical Technology

JUNE 30, 2025

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The FDA Law Blog

APRIL 25, 2024

Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. l)(1) (e.g.,

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ISPE

MAY 10, 2023

3M explores New Label-As-A-Service Concept with Blockchain on Azure to Stop Counterfeit Pharmaceuticals.” Each issue of Pharmaceutical Engineering magazine features thought-provoking content that is available to Members only, but NOW we're giving you exclusive access to see what you've been missing out on. 5 (2003): 395–413.

Chemotherapy 52

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ISPE

MARCH 29, 2023

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

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ISPE

MARCH 29, 2023

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

Documentation 52

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ISPE

MARCH 15, 2023

query=environment Labeling and Organization There are various ways to group the many types of environmental sustainability challenges and goals. Table 2: Organization and labeling examples for environmental sustainability issues. 33 Fixtures and fittings with a WaterSense label, can achieve a 20% reduction in indoor water use.

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Pharmaceutical Technology

JULY 8, 2025

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pharmaphorum

NOVEMBER 29, 2022

However, Science Magazine and STAT have reported two different patient deaths in the trial, based on not-yet-public adverse event reports and interviews with people familiar with the trial. STAT reported last month that a male patient died in June of a cerebral haemorrhage after taking the drug along with the common anticoagulant Eliquis.

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ISPE

AUGUST 30, 2022

The original molecular weight (MW) specification for polypropylene glycol 2000 (PPG) of 1800–2200 was based on the Food Chemical Codex monograph (90%–110% of label) and not based on a scientific understanding of the process/product requirements. You may unsubscribe from these ISPE communications at any time. Company Name.

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Pharmaceutical Technology

JULY 8, 2025

RFK Jr has also blocked CDC communications, cancelled vaccine panel meetings at the FDA and CDC without explanation, and initiated investigations into links between vaccines and autism. RFK Jr axed all 17 previous members and replaced them with well-known vaccine sceptics and individuals who lack public health expertise.

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