Pharma Leaders

APRIL 3, 2025

This potential stems from accelerating drug discovery, streamlining development and approval processes, and optimizing marketing strategies—fundamentally reshaping the entire drug development lifecycle. This capability extends beyond initial drug discovery stages, encompassing clinical trials and post-approval monitoring.

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European Pharmaceutical Review

APRIL 21, 2025

For the first time in over ten years, the US Food and Drug Administration (FDA) has approved a new targeted treatment for chronic spontaneous urticaria. The European Medicines Agency (EMA) authorised its use for paediatric patients with eosinophilic esophagitis.

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European Pharmaceutical Review

JUNE 12, 2025

Regulatory bodies like the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) are emphasising the importance of data quality for AI applications in healthcare. These factors have created an ecosystem that allows MLM to address the challenges of drug development.

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Pharmaceutical Commerce

JUNE 17, 2025

Structuring patient assistance programs as independent non-profit foundations helps pharmaceutical companies reduce regulatory and legal exposure while allowing for more holistic, patient-centered support. Addressing social drivers of health improves patient outcomes.

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European Pharmaceutical Review

NOVEMBER 19, 2024

Radioligand therapy – potential in oncology “We are delighted to collaborate with Ratio to advance this [radioligand therapy] candidate and work together to bring forward additional therapeutic options for patients with difficult-to-treat cancer,” stated Fiona Marshall , President of Biomedical Research at Novartis.

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European Pharmaceutical Review

FEBRUARY 12, 2025

The European Commission has approved acoramidis as the first near complete TTR stabiliser (90 percent) to treat transthyretin amyloidosis in adults with cardiomyopathy (ATTR-CM) patients in the US and EU. The US Food and Drug Administration (FDA) granted approval of acoramidis as Attruby as a near complete TTR stabiliser in November 2024.

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European Pharmaceutical Review

MAY 30, 2025

New, 96-week trial data show that relapsing multiple sclerosis (RMS) patients given Roches Brutons tyrosine kinase (BTK) inhibitor maintained low levels of disease activity for up to two years. These results are from the Phase II FENopta open-label extension (OLE) study of oral fenebrutinib.

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European Pharmaceutical Review

JUNE 16, 2025

The commitment also aligns with the company ’s goal of serving the growing patient population in the US. Since 2017, the firm’s workforce in the US has expanded by 73 percent, facilitating 15 US Food and Drug Administration (FDA) approvals or indication expansions.

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Cesare Ferrari

MAY 10, 2025

Its market success was driven by solid clinical trials, specialists’ adoption, and effective marketing campaigns emphasizing its ability to reduce fragility fractures in patients. Key approaches included: Formulation Enhancements: The first step was addressing a key pain point of the drug—difficult administration.

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European Pharmaceutical Review

JUNE 27, 2025

CGTs have positioned themselves as the new superhero drugs, swooping in to challenge unmet clinical needs, with the potential to establish new cures for previously life-limiting conditions and opportunities for one-time approaches to treating diseases. However, investment to bring these novel treatments to market in the region is a challenge.

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European Pharmaceutical Review

MARCH 27, 2025

A new industry survey from the Biotechnology Innovation Organization (BIO) highlights the vulnerability of supply that proposed tariffs would put on medicines, and its impact on patient access. This makes supply of medicines vulnerable especially to proposed tariffs on the EU, China, and Canada, according to BIO. .

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European Pharmaceutical Review

NOVEMBER 21, 2024

In June, the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) rejected 1 Lykos Therapeutics’ psychedelic new drug application (NDA) for midomafetamine (MDMA) capsules used alongside MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD) in adults.

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Pharma Marketing Network

MARCH 11, 2025

Which platforms provide valuable insights for reaching healthcare professionals (HCPs) and patients? Digital platforms provide a way to streamline outreach efforts, measure campaign performance, and engage with both healthcare professionals and patients.

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Pharmaceutical Technology

JUNE 25, 2025

MGDs class drugs that act as molecular adhesives, enabling targeted degradation of a protein. Kymera’s drugs are designed to selectively eliminate cyclin-dependent kinase 2 (CDK2) proteins. Can pharma tariffs “Make America Manufacture Again”? AstraZeneca, Pfizer, and Incyte all have candidates in trials that inhibit CDK2.

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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. Credit: Volha_R/Shutterstock.

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Pharmaceutical Technology

JUNE 25, 2025

Biopharmaceutical companies developing Alzheimer’s disease innovator drugs have witnessed a flurry of acquisitions over the past few years, surging in total deal value by more than 780% from $2 billion in 2022 to almost $18 billion in 2024. Can pharma tariffs “Make America Manufacture Again”? Credit: JLStock via Shutterstock.

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European Pharmaceutical Review

MAY 2, 2025

The US Food and Drug Administration (FDA) has approved Zevaskyn (prademagene zamikeracel) as the first autologous cell-based gene therapy for treating recessive dystrophic epidermolysis bullosa (RDEB) wounds. Also known as pz-cel, the cell sheet-based treatment is applied via a single surgical application.

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European Pharmaceutical Review

DECEMBER 30, 2024

Numerous groundbreaking advances have shown these therapies hold potential to revolutionise how we treat, and potentially cure, many conditions, including for patients with underlying genetic or cellular causes of disease that have been difficult to treat with conventionalapproaches.

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PM360

JULY 3, 2025

A great deal of exciting work has been done in drug design and screening. If we look at the drug development process, I think there are three areas where AI can be super helpful: An AI agent that can help scientists and clinicians answer any questions they might have. Much of the work I have seen so far focuses on research.

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Pharmaceutical Technology

JUNE 25, 2025

Robert Barrie June 25, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook PET scans play in an integral part in patients receiving anti-amyloid therapies. Despite reimbursement challenges for the two drugs, revenue for them is expected to surge in the coming decade. Can pharma tariffs “Make America Manufacture Again”?

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Pharmaceutical Technology

JUNE 25, 2025

The US Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s Dupixent (dupilumab) as a treatment option for adults with bullous pemphigoid (BP), a condition that predominantly affects the elderly. Can pharma tariffs “Make America Manufacture Again”? Credit: Toa55/Shutterstock.

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Evolve Your Success

APRIL 23, 2025

From pioneering the heart failure treatment device, Ferosix, to making groundbreaking strides in home healthcare, Jasper unveils how cutting-edge technology is reducing hospital visits and revolutionizing patient care. Insurance companies should like it, Patients should like it, Doctors should like it, and so that’s been the battle.

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Pharmaceutical Technology

JUNE 25, 2025

The RAS(ON) inhibitor portfolio is targeted at patients with RAS-addicted cancers. Revolution Medicines CEO and chairman Mark Goldsmith stated: “Today’s announcement represents a major boost to our bold vision on behalf of patients with RAS-addicted cancers. Can pharma tariffs “Make America Manufacture Again”?

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Nixon Gwilt Law

JUNE 25, 2025

Artificial intelligence (AI) is transforming healthcare by enhancing diagnostics, personalizing treatments, and improving patient engagement. Food and Drug Administration (FDA) is building a flexible, forward-looking framework to govern AI/ML-enabled software as a medical device (SaMD). In response, the U.S.

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Pharmaceutical Technology

JUNE 6, 2025

wants to ensure the ensuing the US does not lag behind other countries in drug development. We are going to make this country the hub of biotechnology innovation,” RFK Jr said during a US Food and Drug Administration (FDA) roundtable on cell and gene therapy on 5 June. Can pharma tariffs “Make America Manufacture Again”?

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Pharmaceutical Technology

JUNE 19, 2025

By GlobalData Learn more about Strategic Intelligence The company then plans to expand into a Phase Ib proof-of-concept trial in patients with KCNT1-related epilepsy in early 2026. The US Food and Drug Administration (FDA) has awarded ABS-1230 both orphan drug and rare paediatric designations.

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PharmaTech

JUNE 24, 2025

In May 2024, the US Food and Drug Administration (FDA) approved Moderna’s next-generation base-modified mRNA-lipid nanoparticle (LNP) respiratory syncytial virus (RSV) vaccine mRESVIA (mRNA-1345) in adults aged 60 years and older with lower respiratory tract disease (5).

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Pharmaceutical Technology

JUNE 9, 2025

YolTech Therapeutics has received the US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application for YOLT-101 to treat heterozygous familial hypercholesterolemia (HeFH). Can pharma tariffs “Make America Manufacture Again”? Credit: aipicte/Shutterstock.

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European Pharmaceutical Review

JULY 10, 2025

The US Food and Drug Administration (FDA) approved ohtuvayre in June 2024 as maintenance therapy for adults with chronic obstructive pulmonary disease (COPD). He shared that the acquisition is intended to accelerate the potential of ohtuvayre to reach more patients living with COPD.

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Pharmaceutical Technology

JULY 10, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest E. 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).

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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.

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Pharmaceutical Technology

JUNE 18, 2025

Makary talked about his vision for the FDA, expedited programmes for drug review and the use of artificial intelligence (AI) tools. Reports Use of Artificial Intelligence in Pharmaceutical Drug Development a. Go deeper with GlobalData Reports Outlook for Viral Vector Contract Manufacturing - Gene Therapies, C.

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Pharmaceutical Technology

JUNE 18, 2025

Robert Barrie and Manasi Vaidya June 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Pharma companies need to demonstrate US-centric potential for the drug to qualify for the new programme. Pharma companies need to demonstrate US-centric potential for the drug to qualify for the new programme.

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Pharmaceutical Technology

JULY 2, 2025

Gilead’s recently approved drug for HIV prevention, Yeztugo (lenacapavir), has the potential to transform the pre-exposure prophylaxis (PrEP) sector in the US, according to market analysts. How will RFK Jr’s American dream for vaccines play out? Credit: Marc Bruxelle via Shutterstock.

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Pharmaceutical Technology

JUNE 20, 2025

Robert Barrie June 20, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The positive opinion issued by the EMA’s Committee for Medicinal Products for Human Use (CHMP) signals a strong chance that its drug will be approved. Piotr Swat via Shutterstock. A decision is expected in August 2025.

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Pharmaceutical Technology

JUNE 9, 2025

Exxua, developed by Fabre-Kramer Pharmaceuticals, is a selective serotonin 5HT1a receptor agonist that has gained approval from the US Food and Drug Administration (FDA) for treating MDD in adults. Can pharma tariffs “Make America Manufacture Again”? Don’t let policy changes catch you off guard.

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PM360

JUNE 13, 2025

This gap risks creating products and services that fail to meet patient and HCP needs. TRENDSETTING Expanded Marketing Approval for Alzheimer’s Treatment The Australian Therapeutic Goods Administration (TGA) has granted marketing authorization for Kisunla (donanemab) from Eli Lilly and Company.

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