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Nasal spray could help prevent depression relapse
SPRAVATO® nasal spray helped treatment-resistant depression patients remain remission and relapse free in a Phase III trial.
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Therapeutics
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Promising schizophrenia drug faces tough competition
A schizophrenia drug that could reduce the risk of patient relapse is at risk of being hidden in a crowded long-acting injectable market.
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First patient dosed with novel RNA modifying enzyme inhibitor
A Phase I trial for solid tumours has begun to assess STC-15, the first RNA methyltransferase modifying enzyme inhibitor.
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EC approves Libtayo® for metastatic cervical cancer
The European Commission has approved Libtayo® for cervical cancer and disease progression while on or after platinum-based chemotherapy, due to positive Phase III trial results.
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CAR-T therapy aids lupus remission
Researchers demonstrated promising early results for a personalised CAR T-cell therapy, which facilitated remission for lupus patients treated with the anti-CD19 treatment.
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NICE recommends combo therapy for gastroesophageal cancer
Nivolumab together with chemotherapy has been recommended in NICE final draft guidance for treatment of gastroesophageal cancer.
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EMA launches quality control group to aid medicine innovation
A new regulatory group, part of the European Medicines Agency, will aid innovative approaches for the development and quality control of medicines, including new technologies for EU patients.
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FDA approves first gene therapy for Haemophilia B
Hemgenix, the first gene therapy for adults with Haemophilia B has been approved by the US Food and Drug Administration (FDA).
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First clinical trial to test novel heart attack drug
The first clinical trial for new heart attack drug glenzocimab, will evaluate its ability to reduce heart damage following a heart attack.
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Clinical trials authorised for 3D-printed ulcerative colitis drug
The FDA gives clinical trial clearance to 3D-printed colon-targeted oral drug for ulcerative colitis, to help improve safety of the dosage release.
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Merck to acquire Imago for $1.35 billion
Merck has signed agreement to acquire Imago for $1.35 billion to further investigate potential of bomedemstat for myeloproliferative neoplasms and other bone marrow diseases.
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FDA priority review for AbbVie lymphoma bispecific antibody
The FDA has accepted priority review of epcoritamab for adults with relapsed/refractory large B-cell lymphoma, which could be the first subcutaneous bispecific antibody for large B-cell lymphoma.
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Therapeutic-first for cold agglutinin disease haemolytic anaemia
The European Commission has approved Enjaymo®, the first-and-only approved therapeutic for haemolytic anaemia in adults with cold agglutinin disease.
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First-in-human gene therapy trial for major cardiac syndrome
The US Food & Drug Administration (FDA) has approved the first-in-human gene therapy trial for heart failure patients with preserved ejection fraction.
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FDA approves first drug to delay type 1 diabetes
The US Food and Drug Administration (FDA) has approved Tzield, the first drug that can help delay the onset of stage 3 type 1 diabetes in patients over eight years old with stage 2 type 1 diabetes.
