Pharmaceutical Technology

JUNE 18, 2025

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”?

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Pharmaceutical Technology

JULY 4, 2025

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Pharmaceutical Technology

JUNE 27, 2025

Bristol Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has given approval to label updates for its CAR T cell therapies, Breyanzi (lisocabtagene maraleucel; liso-cel) and Abecma (idecabtagene vicleucel; ide-cel) to treat multiple myeloma. Credit: Saiful52 / Shutterstock.

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Pharmaceutical Technology

JUNE 17, 2025

Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights. Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JULY 7, 2025

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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Pharmaceutical Technology

JULY 21, 2025

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Pharmaceutical Technology

JUNE 20, 2025

Madrigal accessed a large US market when it won accelerated US Food and Drug Administration (FDA) approval in March 2024 for the first MASH treatment in the region. Can pharma tariffs “Make America Manufacture Again”? If approved in Europe, Rezdiffra would have the same indication.

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Pharmaceutical Technology

JULY 1, 2025

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Pharmaceutical Technology

JULY 1, 2025

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Pharmaceutical Technology

JULY 10, 2025

Transcend Therapeutics has announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to TSND-201, a rapid-acting neuroplastogen, for the treatment of post-traumatic stress disorder (PTSD). Credit: Andrey_Popov/Shutterstock. Stay proactive with real-time data and expert analysis.

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Pharmaceutical Technology

JULY 21, 2025

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Pharmaceutical Technology

JUNE 25, 2025

The first tranche will be received by Revolution, following US Food and Drug Administration (FDA) approval of daraxonrasib to treat metastatic PDAC by January 2028. Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights. Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JULY 25, 2025

Meanwhile, the US Food and Drug Administration (FDA) has extended the review period for the biologics licence application (BLA) submitted by the company for Blenrep combinations for the same indication. Give your business an edge with our leading industry insights. Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JUNE 19, 2025

The US Food and Drug Administration (FDA) has awarded ABS-1230 both orphan drug and rare paediatric designations. Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights. Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JULY 2, 2025

US market provides uptake hint The US Food and Drug Administration (FDA) approved Alyftrek in December 2024 , providing a window into market dynamics for the drug. With this approval, we are one step closer to our ultimate goal of restoring normal levels of CFTR function in people living with cystic fibrosis.”

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Pharmaceutical Technology

JULY 11, 2025

In a move towards transparency, the US Food and Drug Administration (FDA) has published more than 200 archived complete response letters (CRLs), which detail reasons for non-approval of drug applications submitted between 2020 and 2024. How will RFK Jr’s American dream for vaccines play out? Credit: Tada Images/Shutterstock.

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Pharmaceutical Technology

JULY 24, 2025

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Pharmaceutical Technology

JULY 23, 2025

EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Give your business an edge with our leading industry insights. Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JUNE 25, 2025

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. Last month, the FDA approved the Lumipulse G test , the first blood test to help diagnose the disease.

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Pharmaceutical Technology

JULY 10, 2025

Find out more The transaction will enhance Merck’s cardio-pulmonary pipeline and portfolio with the addition of Ohtuvayre (ensifentrine), an FDA-approved treatment for chronic obstructive pulmonary disease (COPD) in adults. Credit: Merck & Co., Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JULY 9, 2025

Image credit: Thanos Psimidis / Arena International With the US Food and Drug Administration (FDA) shifting its clinical trial regulations in recent years, working closely with regulators at the early stages of trial design is becoming increasingly important for successfully executing an oncology trial.

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Pharmaceutical Technology

JULY 2, 2025

Ogsiveo (nirogacestat) is approved by the Food and Drug Administration (FDA) for adults with progressing desmoid tumours requiring systemic treatment. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) also recommended its approval in June 2025.

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Pharmaceutical Technology

JULY 8, 2025

How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights. Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JULY 8, 2025

How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights. Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JULY 2, 2025

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Pharmaceutical Technology

JUNE 30, 2025

How will RFK Jr’s American dream for vaccines play out? of equity shares from JB employees at the same price per share as offered to KKR. Give your business an edge with our leading industry insights. Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JUNE 18, 2025

Manasi Vaidya June 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook BIO President John Crowley [L] speaking to US FDA Commissioner Dr Marty Makary [R] at the BIO International Convention in Boston. Can pharma tariffs “Make America Manufacture Again”? Data Insights The gold standard of business intelligence.

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Pharmaceutical Technology

JULY 24, 2025

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Pharmaceutical Technology

JUNE 18, 2025

The US Food and Drug Administration (FDA) has created a new priority review voucher (PRV) framework to expedite the drug approval process for pharma companies prioritising US interests. Can pharma tariffs “Make America Manufacture Again”? Credit: voffka23 via Shutterstock.

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Pharmaceutical Technology

JULY 1, 2025

The US Food and Drug Administration (FDA) has approved Takeda’s new immunoglobulin (IG) therapy, Gammagard liquid ERC [immune globulin infusion (human)], to treat primary immunodeficiency (PI) in individuals aged two years and above. Credit: HenadziPechan/Shutterstock. Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JULY 2, 2025

The US Food and Drug Administration (FDA) approved Yeztugo last month , bringing a more convenient PrEP option for adults and adolescents at risk of HIV exposure. The Elton John AIDS Foundation said it was “pleased to hear about the FDA approval of lenacapavir as a new and extremely effective prevention technology for HIV transmission”.

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Pharmaceutical Technology

JULY 15, 2025

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Pharmaceutical Technology

JUNE 12, 2025

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Pharmaceutical Technology

JULY 23, 2025

EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Give your business an edge with our leading industry insights. Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JUNE 30, 2025

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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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”? A drug with a recent approval extension in the US, though not the UK, was Supernus Pharmaceuticals’ Qelbree (viloxazine extended-release capsules).

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