First faecal microbiota product approved for C. diff
The first faecal microbiota product to prevent recurrence of Clostridioides difficile infection in adults has been approved by the FDA.
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The first faecal microbiota product to prevent recurrence of Clostridioides difficile infection in adults has been approved by the FDA.
The European Commission has granted the first paediatric marketing authorisation for Gilead's low-dose Biktarvy® HIV tablet.
REM-001, a photodynamic therapy for cutaneous metastatic breast cancer has been given Fast Track designation by the US Food and Drug Administration (FDA).
A patient-centric legal framework intends to return clinical trial data to study participants, ready for re-use in further research or healthcare practice.
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.
Nivolumab together with chemotherapy has been recommended in NICE final draft guidance for treatment of gastroesophageal cancer.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 FDA gives clinical trial clearance to 3D-printed colon-targeted oral drug for ulcerative colitis, to help improve safety of the dosage release.
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.
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.
Upstaza™, approved for UK patients 18 months and over, is the first gene replacement therapy infused directly into the brain for the treatment of AADC deficiency.
New therapy Mobocertinib, recommended by NICE, helps slow growth of EGFR-positive non-small-cell lung cancer in platinum-based chemo-treated patients.