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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.
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The US Food and Drug Administration (FDA)
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Whole genome sequencing and analysis of live biotherapeutic products
Here, Snehit Satish Mhatre and Michael Timm of Eurofins discuss considerations and recommendations for the testing of live biotherapeutic products.
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The potential of tryptamines in treatment-resistant depression
There is growing interest in the use of psychedelic-assisted therapy for treatment of mental health conditions. Here, Guy Goodwin, Chief Medical Officer of COMPASS Pathways, explores the potential of tryptamines to treat depression, sharing results from a recent clinical trial.
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European Commission approves Pluvicto® for prostate cancer
The European Commission has approved Pluvicto® as the first targeted radioligand therapy for advanced prostate cancer, based on significant results from the Phase III VISION trial.
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The lingering menace of diethylene glycol / ethylene glycol adulteration
Although it was first identified in the 1930s, diethylene and ethylene glycol contamination remains an issue today, as Dave Elder explains.
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FDA approves Rezlidhia™ for leukaemia
Rezlidhia™ has been approved for adults with mIDH1 relapsed/refractory acute myeloid leukaemia by the US Food and Drug Administration (FDA).
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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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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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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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EMA validates AbbVie lymphoma bispecific antibody application
AbbVie's marketing application for epcoritamab in adults with relapsed/refractory diffuse large B-cell lymphoma has been validated by the European Medicines Agency.
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AstraZeneca dual immunotherapy approved for US liver cancer patients
The FDA has approved Imfinzi™ combined with Imjudo for adults with unresectable liver cancer, based on a lower risk of death compared to only sorafenib.
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Three-dose vaccine prevents HIV patients getting hepatitis B
Clinical trial results suggest adult HIV patients can be protected against hepatitis B with a three-dose vaccine series.
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$38 million will fund rare disease research over four-year period
Research for rare diseases including ALS will be supported over the next four years by $38 million in FDA funding.
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First FDA pregnancy-approved Pertussis vaccine to protect newborns
The FDA has approved Boostrix, the first vaccine for pregnant women in their third trimester, to stop whooping cough (Pertussis) in infants below two months.
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Novel cancer therapeutic synthesised by Stanford researchers
The natural compound tigilanol tiglate was produced in a lab for the first time by scientists at Stanford University, suggesting it could provide treatment for a variety of cancers.
