Newsroom
153 articles
Featured Migraine 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…
Featured EMA 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…
Featured Taking 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…
Featured Today, 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…
Featured Pilots 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…
Featured EMA 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…
Featured EMA 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…
Featured The 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…
Featured An 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…
Featured Highlights 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…
Featured The 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…
Featured FDA 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…
Featured FDA 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…
Featured New combined antibiotic approved to treat adult patients with severe infections of the urinary tract and hospital-acquired pneumonia The Medicines and Healthcare products Regulatory Agency (MHRA) has today…
Featured EMA’s safety committee (PRAC) concluded that there was insufficient evidence to establish a causal association between the COVID-19 vaccines Comirnaty and Spikevax and cases of postmenopausal bleeding. Postmenopausal…
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