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CGT Catapult to bolster new UK life sciences campus
The Cell and Gene Therapy Catapult (CGT Catapult) is set to be involved in the establishment of one of the largest life sciences campuses in Europe.
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Clinical Development
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Pierre Fabre to lead commercialisation of EBVALLO®
Following transfer of the European Commission marketing authorisation from Atara, Pierre Fabre will lead commercialisation of EBVALLO® in Europe.
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Could oral difelikefalin be first FDA-approved drug for notalgia paresthetica?
A study by Icahn School of Medicine at Mount Sinai researchers showed oral difelikefalin could potentially relieve itching associated with notalgia paresthetica.
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CD19 CAR-T agents to boost blood cancer market
GlobalData says CD19 CAR-T agents are expected to treat over 13,000 blood cancer patients annually by 2031, driving sales of Breyanzi and Yescarta.
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FDA gives first RMAT designation to a cardiac gene therapy
A regenerative medicine advanced therapy (RMAT) designation has been given to a gene therapy for Danon disease by the US Food and Drug Administration (FDA).
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Forxiga approved in EU for chronic heart failure
Forxiga (dapagliflozin) has been approved in the EU for chronic heart failure across the full spectrum of left ventricular ejection fraction.
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MSD and Nectin to collaborate on clinical trial for KEYTRUDA® combination
MSD/Merck and Nectin Therapeutics have agreed to collaborate on a clinical trial for KEYTRUDA® in combination with monoclonal antibody NTX1088.
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BMS in-licensed PKC theta inhibitor enters clinical trials
A potentially first-in-class PKC theta inhibitor, in development for immunology and inflammation indications, has entered first-in-human trials in the US.
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First-in-class therapy shows potential for chronic fibrosis
A novel, first-in-class oral therapy showed meaningful improvement in over half of scleroderma patients in a Phase II trial for serious inflammatory and fibrotic diseases.
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Pembrolizumab plus chemo improves endometrial cancer survival
An interim analysis of a Phase III trial showed pembrolizumab plus chemotherapy significantly improved survival in endometrial cancer.
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Clinical Trials Information System mandatory in EU
Use of the Clinical Trials Information System is now mandatory for new clinical trial applications in the EU, says the European Medicines Agency.
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First medicine approved in EU for eosinophilic esophagitis
Dupixent® has been approved by European Commission as the first and only targeted medicine indicated for eosinophilic esophagitis.
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FDA approves first BTK inhibitor for lymphoma
The first BTK inhibitor of any kind approved for mantle cell lymphoma treated with a covalent BTK inhibitor, has been granted FDA approval.
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Monoclonal antibody could prevent malaria, study shows
Based on recent research, a "potential game changer” approach could offer a practical way to use monoclonal antibody therapies for malaria in Africa.
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Enhertu approved in EU for HER2-low breast cancer
The European Commission has approved Enhertu in the EU as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
