European Pharmaceutical Review

MARCH 26, 2025

The US Food and Drug Administration (FDA) has approved Blujepa ( gepotidacin ) antibiotic for uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients aged 12 years old and over.

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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. Sanofi and Regeneron Pharmaceuticals collaborated to develop Dupixent (dupilumab).

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Pharmaceutical Technology

MAY 15, 2025

Kaerus Bioscience has received US Food and Drug Administrations (FDA) designations for KER-0193 to treat Fragile X syndrome (FXS).

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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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European Pharmaceutical Review

NOVEMBER 19, 2024

.” In a Q&A with EPR last year, Hoppin and Ratio’s Director, President and Chief Scientific Officer, Dr John Babich, described that “there is great hope of this class of drug specifically to work in conjunction with immunotherapeutics, given the lack of toxicity of radiopharmaceuticals in general compared to most chemotherapies.”

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European Pharmaceutical Review

FEBRUARY 12, 2025

The US Food and Drug Administration (FDA) granted approval of acoramidis as Attruby as a near complete TTR stabiliser in November 2024. Under a collaboration agreed with Bayer in March 2024, BridgeBio will receive a $75 million upon EU approval of acoramidis.

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European Pharmaceutical Review

JUNE 16, 2025

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. In March, the company announced promising Phase III trial results for three drugs being investigated to treat plaque psoriasis, including two biologics.

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European Pharmaceutical Review

MAY 30, 2025

The drug dually inhibits of both B-cell and microglia activation, which, according to Roche, may reduce both disease activity and disability progression. Article: Preparing for a new era in the rare disease sector The post Roche reports long-term capabilities of multiple sclerosis drug appeared first on European Pharmaceutical Review.

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Pharmaceutical Technology

MAY 15, 2025

The US Food and Drug Administration (FDA) has accepted BioCryst Pharmaceuticals new drug application (NDA) for Orladeyo.

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Cesare Ferrari

MAY 10, 2025

Key approaches included: Formulation Enhancements: The first step was addressing a key pain point of the drug—difficult administration. Alendronate must be taken in the morning on an empty stomach, with a full glass of water, and no other food or drinks for 30 minutes.

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European Pharmaceutical Review

MARCH 27, 2025

According to the findings, nearly 90 percent of US biotechs rely on imported components for at least half of their products approved by the US Food and Drug Administration. 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

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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Pharmaceutical Commerce

JUNE 17, 2025

Separating PAPs from commercial entities enhances public trust, provides access to diverse funding sources, and supports sustainable, mission-driven care—despite challenges like funding stability and administrative burden. Administrative burden. This can create uncertainty and impact long-term planning for an independent foundation.

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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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PharmaTech

NOVEMBER 5, 2024

In the wake of the Food and Drug Administration's (FDA's) latest guidance on nitrosamine contamination, ensuring compliance and safeguarding pharmaceutical products is more critical than ever.

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Pharmaceutical Technology

MAY 29, 2025

Eton Pharmaceuticals NDA for Khindivi, an oral solution of hydrocortisone, has received US Food and Drug Administration (FDA) approval.

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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 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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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 13, 2025

GSK previously received US Food and Drug Administration approval for Nucala (mepolizumab) as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease that is inadequately controlled, and an eosinophilic phenotype. Can pharma tariffs “Make America Manufacture Again”?

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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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Pharma Marketing Network

MARCH 11, 2025

Strict guidelines from the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) require marketers to ensure transparency and accuracy in all communications. Resources like the FDAs OPDP (Office of Prescription Drug Promotion) provide guidance on drug advertising and communication.

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European Pharmaceutical Review

NOVEMBER 21, 2024

The LAL reagents included in the cartridges are licensed by the US Food and Drug Administration (FDA). Are LAL and rCR cartridges licensed by the FDA? However, recombinant reagents, including both rFC and rCR, are not currently licensed.

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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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European Pharmaceutical Review

DECEMBER 30, 2024

Internet] US Food and Drug Administration. [Internet] Cell and Gene Therapy Catapult. cited 2024Aug]. Available from: [link] 5. Centers of Excellence in Regulatory Science and Innovation (CERSIs). cited 2024Aug]. Available from: [link] 6.

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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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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. Despite reimbursement challenges for the two drugs, revenue for them is expected to surge in the coming decade.

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Pharmaceutical Technology

MAY 23, 2025

GSK has received approval from the US Food and Drug Administration (FDA) for its monoclonal antibody, Nucala (mepolizumab).

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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. The US regulator has granted orphan drug, fast track and rare paediatric drug designations to the therapy. Can pharma tariffs “Make America Manufacture Again”?

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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 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”?

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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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Nixon Gwilt Law

JUNE 25, 2025

Food and Drug Administration (FDA) is building a flexible, forward-looking framework to govern AI/ML-enabled software as a medical device (SaMD). Draft Guidance on AI for Regulatory Decision-Making in Drugs/Biologics (Jan. But AI’s ability to learn, adapt, and evolve over time poses unique challenges for regulators.

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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 16, 2025

By GlobalData Learn more about Strategic Intelligence Zurzuvae, whose ownership rights will now transfer to Supernus, is the only US Food and Drug Administration (FDA)-approved pill to treat postpartum depression. Can pharma tariffs “Make America Manufacture Again”? Stay proactive with real-time data and expert analysis.

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PharmaTech

JULY 11, 2025

A 2015 cross-sectional study published in BMJ found that drug developers omitted around 85% of safety and efficacy concerns noted by the FDA in their public statements (2). Unprecedented Move Previously, the FDA had not routinely shared CRLs publicly. Sponsors often disclosed minimal information when announcing a non-approval.

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