Newsroom
155 articles
FeaturedThe Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new formulation of the medicine ocrelizumab (Ocrevus 920mg solution for injection) to treat relapsing forms of multiple…
FeaturedToday, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test…
FeaturedMigraine and antiseizure medication topiramate must no longer be prescribed to women and girls unless they fulfil the requirements of a Pregnancy Prevention Programme. Following a major safety…
FeaturedEMA has recommended granting a marketing authorisation in the European Union (EU) for Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension (PAH), in combination with other…
FeaturedTaking warfarin and tramadol together can cause harmful drug interactions, which can raise the International Normalized Ratio (INR), and result in severe bruising and bleeding, which in some…
FeaturedToday, the U.S. Food and Drug Administration expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the treatment of Duchenne muscular dystrophy (DMD) for ambulatory and…
FeaturedPilots are part of ACT EU collaboration to foster high-quality clinical research in the EU. The Accelerating Clinical Trials in the EU (ACT EU) initiative is today launching…
FeaturedEMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Durveqtix (fidanacogene elaparvovec) to treat severe and moderately severe haemophilia B in adults who…
FeaturedEMA has recommended granting a marketing authorisation in the European Union (EU) for Ixchiq, the first vaccine in the EU to protect adults 18 years and older against…
FeaturedThe U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the following…
FeaturedAn MHRA and NICE partnership, funded by Wellcome, is addressing key challenges for regulating and evaluating digital mental health technologies (DMHTs) with input from patients, the public and…
FeaturedHighlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024 meeting-Hydroxyprogesterone caproate medicines to be suspended from the EU market EMA’s safety committee (PRAC) has recommended the…
FeaturedThe MHRA will introduce a patient alert card to increase awareness among men taking finasteride about potential psychiatric and sexual side effects, MHRA is asking men taking this…
FeaturedFDA Approves New Treatment for Uncomplicated Urinary Tract Infections Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated…
FeaturedFDA Approves New Antimicrobial Drug for Cattle and Swine Today, the U.S. Food and Drug Administration approved Pradalex (pradofloxacin injection) solution for certain respiratory diseases in cattle and…
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