FDA Fast Track designation for photodynamic cancer therapy
REM-001, a photodynamic therapy for cutaneous metastatic breast cancer has been given Fast Track designation by the US Food and Drug Administration (FDA).
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REM-001, a photodynamic therapy for cutaneous metastatic breast cancer has been given Fast Track designation by the US Food and Drug Administration (FDA).
SPRAVATO® nasal spray helped treatment-resistant depression patients remain remission and relapse free in a Phase III trial.
A schizophrenia drug that could reduce the risk of patient relapse is at risk of being hidden in a crowded long-acting injectable market.
A Phase I trial for solid tumours has begun to assess STC-15, the first RNA methyltransferase modifying enzyme inhibitor.
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.
Researchers demonstrated promising early results for a personalised CAR T-cell therapy, which facilitated remission for lupus patients treated with the anti-CD19 treatment.
Nivolumab together with chemotherapy has been recommended in NICE final draft guidance for treatment of gastroesophageal cancer.
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.
Hemgenix, the first gene therapy for adults with Haemophilia B has been approved by the US Food and Drug Administration (FDA).
The first clinical trial for new heart attack drug glenzocimab, will evaluate its ability to reduce heart damage following a heart attack.
The FDA gives clinical trial clearance to 3D-printed colon-targeted oral drug for ulcerative colitis, to help improve safety of the dosage release.
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.
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.
The European Commission has approved Enjaymo®, the first-and-only approved therapeutic for haemolytic anaemia in adults with cold agglutinin disease.
The US Food & Drug Administration (FDA) has approved the first-in-human gene therapy trial for heart failure patients with preserved ejection fraction.