The FDA has granted Investigational New Drug application to PLX-200 to treat late infantile neuronal ceroid lipofuscinosis (LINCL).
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Rachael Harper (European Pharmaceutical Review)
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EU marketing authorisation has been given to Sunosi (solriamfetol) for excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea.
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.
Ten priority actions have been recommended for the European medicines regulatory network to evolve its approach to data use.
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.
The World Health Organization (WHO) has released new reports which state that a lack of innovation in new antibiotic development is undermining efforts to combat drug-resistant infections.
The US FDA has granted Fast Track Designation to APD418, which is in development as treatment for decompensated heart failure patients.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has said that medicine shortages may negatively impact patient care and deserves serious action.
NICE has asked for more information on Keytruda (pembrolizumab) for untreated metastatic or unresectable recurrent squamous cell head and neck cancer due to uncertainty over clinical trial evidence.
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.
New research has shown that technologies are available for US treatment plants to remove medicines from wastewater but that upgrades can be expensive.
Supplemental new drug application (sNDA) has been approved for an expanded indication of MYCAMINE® for the treatment of invasive candidiasis in paediatric patients under four months old.
NICE has recommended patients in England have access to a new treatment option for treating hyperkalaemia (raised serum potassium levels) in adults.
Functional links between metabolic, cardiovascular and renal diseases, as well as a focus on digital and a personalised approach will shape diabetes drug development in 2020, says new analysis.
The FDA has approved Vascepa (icosapent ethyl) as a secondary therapy to reduce cardiovascular events in adults.