news
FDA grants priority review of glofitamab for lymphoma
Glofitamab for relapsed or refractory large B-cell lymphoma has been granted priority review by the US Food and Drug Administration (FDA).
List view / Grid view
Clinical Trials
news
Could BioNTech’s new partnership accelerate personalised mRNA therapy trials?
The UK Government and BioNTech’s new partnership aims to accelerate clinical trials of personalised immunotherapies for cancer and infectious disease vaccines.
news
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).
news
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.
news
EMA validates Enhertu® Type II variation application for lung cancer
The Type II variation application for Enhertu® for adults with advanced non-small cell lung cancer has been validated by the EMA.
news
Janssen submits marketing application for bispecific antibody
Approval for Janssen’s talquetamab to treat relapsed/refractory multiple myeloma has been submitted to the European Medicines Agency.
news
First patient enrolled in cisplatin-induced ototoxicity Phase II trial
A Phase II proof of concept trial evaluating SENS-401 for cisplatin-induced ototoxicity has enrolled its first patient.
news
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.
news
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.
news
FDA approves first capsid inhibitor for HIV
Gilead’s Sunlenca (lenacapavir) is the first capsid inhibitor to be FDA-approved for treating HIV-1.
news
Moderna finalises plans for UK mRNA vaccine manufacturing centre
Moderna is to build an mRNA vaccine manufacturing centre in the UK after finalising a ten-year agreement with the UK government.
news
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.
news
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.
news
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.
article
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.
