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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Pfizer’s €1.2 billion manufacturing site expansion
Pfizer’s €1.2 billion investment in its Grange Castle site in Dublin is expected to double the plant’s capacity for manufacturing biologics.
mRNA non-vaccine therapeutics to generate $2 billion by 2028
Driven by the approval of pipeline agents, mRNA non-vaccine therapeutics are set to reach $2 billion in sales by 2028, says GlobalData.
Could acoziborole eliminate sleeping sickness in Africa?
Acoziborole showed significant success in clinical studies, suggesting it could simplify treatment and help eradicate sleeping sickness.
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.
First paediatric EC approval of HIV drug
The European Commission has granted the first paediatric marketing authorisation for Gilead's low-dose Biktarvy® HIV tablet.
NEJM publishes lecanemab Alzheimer’s study results
Full study results of Eisai’s Phase III Alzheimer's study suggest lecanemab could slow disease progression.
CPI opens £88 million manufacturing innovation centre
CPI has opened its Medicines Manufacturing Innovation Centre in Scotland to focus on efficient, sustainable manufacturing and advance medicine research.
Radiation with immunotherapy increases lung cancer survival
Phase I study analysis determined immunotherapy with radiation is more effective than radiotherapy alone for metastatic non-small cell lung cancer.
First adaptive clinical trial for flu
A £2.9 million trial, the first adaptive platform trial studying flu treatments, could reduce serious illness in patients.
AstraZeneca to acquire Neogene for $320 million
AstraZeneca is set to acquire Neogene Therapeutics to advance T-cell receptor therapies for hard-to-treat cancers like solid tumours.
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).
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.
Framework to enable re-use of patient clinical data
A patient-centric legal framework intends to return clinical trial data to study participants, ready for re-use in further research or healthcare practice.
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.
