Newsroom
153 articles
Featured The U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants to…
Featured Guiding principles set out how EU medicine regulators can use LLMs in a safe, responsible and effective manner, EMA and the Heads of Medicines Agencies (HMA) have published…
Featured The U.S. Food and Drug Administration expanded the indications of the Insulet SmartAdjust technology, Agency Supports Broader Access to Innovative Technology in Diabetes Management, an interoperable automated glycemic…
Featured The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a product license for the medicine lecanemab (Leqembi) for use in the early stages of Alzheimer’s disease, following…
Featured A new targeted cancer treatment, given in combination with a standard chemotherapy, for adults with stomach (gastric) or gastro-oesophageal junction cancer has been approved by the Medicines and…
Featured First Home Antibody Test Can Inform Patients of Current or Past Infection and Lead to Confirmatory Testing with Health Care Provider, The U.S. Food and Drug Administration granted…
Featured Validating processes is an important step towards establishment of African Medicines Agency, EMA has awarded a grant to the African Medicines Regulatory Harmonisation (AMRH) initiative of the African…
Featured The U.S. Food and Drug Administration approved Tecelra (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received…
Featured The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an adapted Pfizer/BioNTech COVID-19 vaccine (Comirnaty) that targets the JN.1 COVID-19 subvariant. This vaccine triggers the production of…
Featured The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication for semaglutide (Wegovy) to reduce the risk of overweight and obese adults suffering serious heart…
Featured The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the first generic raltegravir medicines to treat adult and paediatric HIV patients who weigh at least 40kg. The…
Featured The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 17 July 2024, approved the medicine vibegron (Obgemsa) to treat the symptoms of overactive bladder (OAB) syndrome in…
Featured The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 17 July 2024, approved the medicine capivasertib (Truqap) for patients with advanced hormone receptor (HR) positive, human epidermal…
Featured The 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…
Featured Today, 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…
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