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The US Food and Drug Administration (FDA) has expanded the indications of an imaging agent developed by GE HealthCare, which will likely put it at the forefront of the Alzheimer’s diagnostics arena. Can pharma tariffs “Make America Manufacture Again”? Credit: Utthapon wiratepsupon via Shutterstock.
Tisento Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its investigational oral medicine, zagociguat, for mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes (MELAS), a rare mitochondrial disease. Can pharma tariffs “Make America Manufacture Again”?
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.
The US Food and Drug Administration (FDA) has approved KalVista Pharmaceuticals’ Ekterly (sebetralstat) as the first and only oral on-demand medication for acute attacks of hereditary angioedema (HAE) in adults and in children aged 12 years and above. Credit: KalVista Pharmaceuticals/Business Wire.
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The US Food and Drug Administration (FDA) has removed the risk evaluation and mitigation strategies (REMS) requirements for all approved autologous chimeric antigen receptor (CAR-T) cell immunotherapies, saying the access barrier is no longer needed for the modality. How will RFK Jr’s American dream for vaccines play out?
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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.
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. A decision by the FDA is expected in H1 2026. MAXSHOT.PL via Shutterstock.
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.” How will RFK Jr’s American dream for vaccines play out?
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Comparing sales from other drugs is tricky because Spevigo is the only US Food and Drug Administration (FDA)-approved treatment specifically for GPP. By GlobalData Learn more about Strategic Intelligence LEO calls Spevigo “the flagship dermatology product” of Boehringer Ingelheim, though the drug’s sales have not been publicly disclosed.
The European approval follows a similar decision made by the US Food and Drug Administration (FDA) in March 2025. Its European label covers a range of cancers, including lung, biliary tract, and liver, amongst others. Imfinzi is a major revenue driver for AstraZeneca, generating around $4.7bn in sales in 2024.
By GlobalData Learn more about Strategic Intelligence Corwin added that Elevidys’s label will likely be updated to reflect the risk of ALF. Sarepta stated the event has been reported to the US Food and Drug Administration (FDA) and global health authorities. Can pharma tariffs “Make America Manufacture Again”?
The US Food and Drug Administration (FDA) has expanded approval of Moderna’s respiratory syncytial virus (RSV) vaccine to include younger adults at risk, though its still uncertain whether the shot will be recommended for broader use in the national immunisation schedule. Can pharma tariffs “Make America Manufacture Again”?
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.
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.
Her career kicked off at 18, when she landed a role at Check Point after successfully cracking a series of online cybersecurity challenges the company had labelled as nearly unsolvable. Image Siwar El Assad 2 July, 2025 AI in pharma Bookmark this Market Access Balancing efficiency with risks: How biopharma companies can.
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.
In May, Moderna withdrew its US marketing application for the dual shot with an acknowledgement that it would need to wait for efficacy data from the mRNA-1010 study before it could refile for FDA approval.
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., l)(1) (e.g.,
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.
As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.
As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.
Food and Drug Administration (FDA) as a treatment for narcolepsy. When using Adderall off-label for depression, there are many things prescribers consider. SSRIs are the most commonly prescribed type of antidepressant —and they are approved by the FDA for this purpose. It’s also approved by the U.S.
Recent US FDA data show that the lack of raw material availability contributes to 27% of drug shortages (see Appendix ). It is considered a moderate change by the FDA (CBE30) and NMPA. This change ranges from a moderate change (CBE-30) by the FDA to a minor change not requiring prior approval by the WHO.
She ranked 2nd on the “Most Powerful International Women” of Fortune Magazine 2019 edition Education: She holds a master’s degree in classics and modern languages from Oxford University Other Affiliations: Emma was appointed as Independent Director for Microsoft board in Dec’19. LinkedIn Total experience: 31 yrs.
Earlier this year, the FDA said it would restrict booster doses in older adults and those at risk of severe illness. 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.
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