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Promising first-in-human study results for orally inhaled antibiotic
Safety results from a first-in-human study showed that orally inhaled murepavadin, a novel macrocycle compound, was well tolerated at all dose levels.
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Pharmapack Europe to launch two new zones in 2024
Two new zones will be launched at Pharmapack Europe in 2024, to support growing demand for biologics, mRNA therapeutics and contract packaging.
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Potential blockbuster drugs to watch in 2023
Lecanemab for Alzheimer's and the first potential gene therapy primed for US launch for haemophilia A are two potential blockbuster Drugs to Watch™, says a 2023 report.
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FDA grants accelerated approval for Leqembi
Alzheimer’s drug Leqembi has been accepted via the US Food and Drug Administration (FDA)’s Accelerated Approval pathway.
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FDA accepts Biologics License Application for RSV vaccine
The Biologics License Application for nirsevimab as the first protective option against RSV for all infants has been accepted by the the US Food and Drug Administration (FDA).
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First-in-class telomerase inhibitor aids transfusion independence in clinical trial
Telomerase inhibitor imetelstat benefitted both major subtypes of lower risk MDS in a Phase III trial for the first time.
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First treatment approval for advanced ASPS
A Phase II trial has led to the FDA approval of atezolizumab for individuals over two years old with advanced alveolar soft part sarcoma.
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EC approves Zynlonta® for large B-cell lymphoma
Antibody drug conjugate Zynlonta® (loncastuximab tesirine) is approved in the European Union for treatment of relapsed or refractory diffuse large B-cell lymphoma.
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FDA approves first capsid inhibitor for HIV
Gilead’s Sunlenca (lenacapavir) is the first capsid inhibitor to be FDA-approved for treating HIV-1.
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Kite to buy Tmunity, expanding its CAR T pipeline
The acquisition of Tmunity Therapeutics supports Kite’s plans to develop next generation CAR T-cell therapies for cancer.
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mRNA therapeutics: a limitless revolution in medicine
Carsten Rudolph and Christian Plank of Ethris, an mRNA therapeutics and vaccine‑focused German biotechnology company, discuss the current state of the art in the field, including delivery systems and administration of mRNA drug candidates to prevent or treat a plethora of diseases.
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Breakthrough gene therapy gives hope for Artemis-SCID
A new gene therapy developed by UC San Francisco has enabled ten young Artemis-SCID patients to achieve full T-cell immunity.
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Lynparza combination approved in EU for advanced prostate cancer
Patients in the EU with an advanced prostate cancer will benefit from a newly approved Lynparza-based treatment combination for the first time.
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MHRA granted almost £1m to advance digital and data regulation
Almost £1m awarded to MHRA will advance projects to innovate AI and microbiome regulation and develop synthetic clinical trial data.
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Psychedelic research: evaluating the fast-evolving regulatory roadmap
In this article, Aman Khera and Dr Christine Moore of Worldwide Clinical Trials share how regulatory agencies are supporting psychedelic research through expedited pathways and outline some of the key considerations for clinical trials sponsors.
