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153 articles
Featured The U.S. Food and Drug Administration issued a draft guidance with the Office for Human Research Protections that will offer suggestions for incorporating tissue biopsies into clinical trials…
Featured The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the conditional marketing authorization of givinostat (Duvyzat), a medication used to treat Duchenne muscular dystrophy (DMD). Givinostat is…
Featured The U.S. Food and Drug Administration authorized Ryoncil (remestemcel-L-rknd), an allogeneic (donor) bone marrow-derived mesenchymal stromal cell (MSC) therapy in order to steroid-refractory acute graft-versus-host disease (SR-aGVHD) in…
Featured The U.S. Food and Drug Administration authorized the use of Crenessity (crinecerfont) in conjunction with glucocorticoids (steroids) to regulate the levels of androgen (a testosterone-like hormone) in adults…
Featured A recent study’s findings indicate that Alofisel, a medication used to treat complex anal fistulas in adults with Crohn’s disease, is ineffective. Based on the information at hand,…
Featured The European Medicines Agency (EMA) has suggested that Welireg (belzutifan) be given a conditional marketing authorization in the EU for people with advanced renal cancer (RCC) who have…
Featured European Medicines Agency (EMA) has recommended granting a marketing authorization in the European Union (EU) for Emcitate (tiratricol), an oral medication for individuals with peripheral thyrotoxicosis (unreasonably elevated…
Featured The Holiday season is a busy time for all of us, our friends and our family. Consequently, we could overlook our health in the chaos to make sure…
Featured The European Medicines Agency (EMA) has suggested expanding the use of Ofev (nintedanib) to treat progressive fibrosing interstitial lung disorders (ILDs) in children and adolescents starting at age…
Featured The updated regulatory framework will expedite trial approvals and promote trial design innovation without affecting patient safety. New laws will be introduced in Parliament to address the need…
Featured The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine flortaucipir (Tauvid), a radiopharmaceutical product given to adults with memory problems so that doctors can perform…
Featured Following a review of its initial opinion, EMA suggests revising the recommendations to reduce the possibility of interactions between the weight loss medication Mysimba (naltrexone/bupropion) and medications that…
Featured The U.S. Food and Drug Administration approved Kebilidi (eladocagene exuparvovec-tneq), a gene therapy based on an adeno-associated virus vector that is recommended for the treatment of patients with…
Featured The Medicines and Healthcare products Regulatory Agency (MHRA) has approved new medicine containing active ingredient sparsentan to treat primary immunoglobulin A nephropathy (IgAN). IgA neuropathy, also known as…
Featured After an agency analysis of the available evidence found that oral phenylephrine is ineffective for this use, The U.S. Food and Drug Administration announced is proposing to remove…
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