Newsroom
307 articles
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…
ImportantThe Product Information (PI) documents for all selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) have been aligned to reflect the risk of sexual…
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…
ImportantNew boxed warnings are being added to the patient information leaflets (PIL) of montelukast due to neuropsychiatric reactions as a result of MHRA review More prominent warnings are…
ImportantThe Medicines and Healthcare products Regulatory Agency (MHRA) has today (3 May 2024) approved two new formulations of the medicine cabotegravir (Apretude 30 mg film-coated tablets and Apretude…
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…
ImportantETF recommends updating COVID-19 vaccines to target new JN.1 variant Updated vaccines will help maintain protection against disease as virus continues to evolve, MA’s Emergency Task Force (ETF)…
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…
ImportantPRAC committee latest meeting doesn’t support a causal association between the Glucagon-Like Peptide-1 receptor agonists (GLP-1) and suicidal and self-injurious thoughts and actions The PRAC has concluded that…
ImportantTGA Updated warnings of faricimab (Vabysmo) retinal vasculitis risk Faricimab is indicated for: Neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular oedema (DMO) Faricimab 6 mg/0.05 mL…
FeaturedNew 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…
ImportantFDA Warns Consumers about Potential for Dangerous Health Effects that can result from Certain Topical Pain Relief Products The U.S. Food and Drug Administration is warning consumers not…
ImportantToday, the U.S. Food and Drug Administration approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), to…
FeaturedEMA’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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