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Trending topics The US FDA has been working in collaboration with GSK towards developing treatment to manage symptoms of patients struggling with autism, thereby on 22nd of September the FDA…
Drug Approvals The FDA just recently approved first time treatment for patients struggling from Barth Syndrome, a rare life-threatening disease which affects the mitochondria, powerhouse of the cell. Barth Syndrome…
Drug Approvals A new treatment path for patients with rare active immunoglobulin G4-related disease after the European Medicine’s Agency decided on extending the therapeutic indication of Uplizna (inebilizumab) to include…
Drug Approvals The Medicines & Healthcare Regulatory Agency (MHRA) has approved vorasidenib (Voranigo) for the treatment of adults and children aged 12 and older with specific types of brain tumors,…
Drug Approvals Patients with von Willebrand disease (VWD) now have expanded treatment options, following the FDA’s approval of Vonvendi for prophylactic use in adults aged 18 and older, as well…
Important Opioid misuse continues being a challenge in the United States, with it being prescribed to about 1 in 5 U.S adults who struggle with chronic pain & which…
Featured A new study in Drug Safety presents the idea of “implied ADR-admissions” a method of using hospital and prescribing data to identify admissions likely caused by medicines. This…
Featured Innovation is progressing each day & with the presence of AI things are starting to look different. Now AI is being utilized in various ways, just recently UK…
Featured The new UK–US partnership will harness joint expertise in evolving technologies to deliver real-world benefits, from accelerating drug discovery with AI and quantum computing to provide patients with…
Featured The Food & Drug Administration has just launched the final guide for Good Clinical Practice Guidance E6(R3). The updated guideline introduces flexible, risk-based approaches to trial design and…
Featured The FDA has just released updated guidance on biosimilar development a big move for manufacturers navigating this space. The update proposes improved clarity, especially around patient safety and…
Featured On the 10th of September, the FDA approved KOSELUGO (selumetinib) granules & capsules for children 1 year or older who suffer from neurofibromatosis type 1 (NF1) and who…
Featured Immune thrombocytopenia an autoimmune disease known for having decreased platelets count which in turn results in frequent bruising & bleeding due to loss of clot formation ability. Patients…
Featured In coordination with the State Office for Health and Social Affairs Berlin (LAGeSo), Esteve Pharmaceuticals GmbH has reported regarding the presence of particles in some of the vials…
Featured On the 21st of May Roche has identified a mistake in Evrysdi product labelling statement & SmPC as they found out it was missing out the point related…
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