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GE HealthCare’s PET imaging agent gains Alzheimer’s label expansion

Pharmaceutical Technology

The updated label for GE HealthCare’s positron emission tomography (PET) imaging agent Vizamyl (flutemetamol F 18 injection) now includes quantification of amyloid in the brain, meaning patients taking an anti-amyloid therapy can be monitored for the drug’s effectiveness. Can pharma tariffs “Make America Manufacture Again”?

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FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications

The FDA Law Blog

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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Bimekizumab shows lasting efficacy at EULAR 2025

Pharma Times

Content News Magazine Advertise Contact Competitions Connect Follow Follow Follow Follow Follow Legal Privacy Policy Terms and Conditions Editorial policy Cookies RSS – feed subscriptions © Copyright PharmaTimes Media Limited 2023 In psoriatic arthritis, 53.2% of biologic-naïve patients and 55.2% This field is required.

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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.

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Bayer’s Eylea market grip set to slip as Alvotech biosimilar closes in

Pharmaceutical Technology

Bayer has responded by eying a label extension that would allow injections of its high-dose version in intervals of up to six months. Can pharma tariffs “Make America Manufacture Again”? Vabysmo generated $4.3bn in sales in 2024, becoming one of Roche’s top-selling drugs, and had high year-over-year growth than Eylea.

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How AI and machine learning are transforming drug discovery

Pharmaceutical Technology

It also identifies off-label usage patterns and relevant comorbidities that may influence therapeutic decisions. Can pharma tariffs “Make America Manufacture Again”?

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FDA approves label updates for BMS’ CAR T cell therapies

Pharmaceutical Technology

June 27, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Label updates have been approved for BMS’ CAR T cell therapies, Breyanzi and Abecma, to treat multiple myeloma. The regulatory agency has also given approval to the removal of the REMS requirement from the product labels. Credit: Saiful52 / Shutterstock.