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Gilteritinib not recommended by NICE for AML treatment
NICE has said it will not recommend gilteritinib for treatment of acute myeloid leukaemia (AML) due to uncertainty around long-term survival expectancy and its cost-effectiveness.
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EC approves Darzalex® in combination with VTd for multiple myeloma
The European Commission (EC) granted marketing authorisation for Darzalex in combination with bortezomib, thalidomide and dexamethasone (VTd) for multiple myeloma patients.
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GSK halts Excedrin production due to manufacturing inconsistencies
GlaxoSmithKline has announced that it will not be manufacturing or distributing some of its Excedrin products after inconsistencies in ingredient transfer and weight.
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FDA announces drug product recall due to lack of sterility assurance
FUSION IV Pharmaceuticals, Inc dba AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products to the user level as they do not adhere to federal guidelines.
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Regulatory expansion submitted for SPRAVATO® (esketamine) nasal spray
Janssen have applied to the EMA to extend the use of esketamine to a short-term treatment for the rapid reduction of depressive symptoms in adults with MDD who are suicidal with the intent.
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Edible security tag for drugs developed to combat counterfeits
Researchers have created a unique edible film to be added onto the surface of drugs which can produce a security key, preventing counterfeits from reaching patients.
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Strengthened regulatory systems are needed to improve drug safety, says report
The report reveals practical regulatory reforms that could move the globe closer to the UN’s goal of achieving universal health coverage by 2030.
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FDA issues alert for cancer risk from Belviq (lorcaserin)
The US FDA has announced a warning to healthcare professionals and patients that the weight management drug Belviq may be a cause of cancer.
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Phase III STRENGTH trial for Epanova in mixed dyslipidaemia will close
On recommendations by an independent committee, AstraZeneca will close its STRENGTH trial for Epanova, which has shown low likelihood of being beneficial to patients with mixed dyslipidaemia.
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Taro Pharmaceuticals voluntarily recalls one lot of lamotrigine tablets
Due to cross-contamination with enalapril maleate, Taro is voluntarily recalling one lot of its lamotrigine tablets at the consumer level.
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T-cell lymphomas treatment trial update announced by Innate Pharma
Enrolment of new patients in the TELLOMAK trial, which has been evaluating the efficacy and safety of lacutamab in patients with advanced T-cell lymphomas, has been suspended.
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Nanoparticle gene therapy drug delivery for paediatric brain cancer tested in mice
A study has shown that PBAE nanoparticles could replace viral vectors in gene therapies and provide a safe treatment option for paediatric brain cancer patients.
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NICE argue for more histology-independent cancer drug evidence
Staff at NICE have co-authored a paper which suggests that new, histology-independent cancer treatments require more clinical evidence before approval recommendation by the institution.
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FDA announces one nizatidine and two ranitidine voluntary recalls
Mylan, Appco Pharma and Denton Pharma are voluntarily recalling nizatidine and ranitidine products due to potential unacceptable levels of NDMA.
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The Advance Value Framework: evaluating the benefits of novel medicines
Researchers have proven their methodology for drug benefit evaluation to be effective as a decision support tool in a study with several European drug evaluation bodies.