Newsroom
307 articles
FeaturedThe Medicines and Healthcare Products Regulatory Agency (MHRA) has authorized elafibranor (Iqirvo) for the treatment of adult patients suffering from primary biliary cholangitis (PBC), a rare form of…
FeaturedHympavzi (marstacimab-hncq) was approved by the U.S. Food and Drug Administration for routine prophylactic use in patients aged 12 and up who have hemophilia A without factor VIII…
FeaturedAn adult COVID-19 vaccine (Comirnaty) that targets the KP.2 subvariant has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA). The immune system’s generation of antibodies…
FeaturedPatients who use insulin pumps or continuous glucose monitors (CGMs) are being asked by the Medicines and Healthcare Products Regulatory Agency (MHRA) to promptly report any safety issues…
FeaturedMarketing permission for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test was given by the U.S. Food and Drug Administration. The test is approved for use without a…
FeaturedThe Medicines and Healthcare products Regulatory Agency (MHRA) has approved leniolisib phosphate (Joenja) to treat a rare immune disease known as activated phosphoinositide 3-kinase delta syndrome or APDS…
FeaturedSteps to maximize the utilization of EU’s specialized resources for expedited evaluations, working together, the European Medicines Agency (EMA) and the European Medicines Regulatory Network aim to increase…
FeaturedCobenfy (xanomeline and trospium chloride) capsules have been approved by the US Food and Drug Administration for oral use in the treatment of adult schizophrenia. Unlike the long-established…
ImportantEMA’s human medicines committee (CHMP) has recommended suspending the marketing authorisation for the sickle cell disease medicine Oxbryta (voxelotor); this measure is taken as a precaution while a…
FeaturedThe Medicines and Healthcare products Regulatory Agency (MHRA) approved the new medicine fruquintinib (Fruzaqla) to care for adult patients who have colorectal cancer that has spread (CRC). When…
FeaturedThe U.S. Food and Drug Administration approved FluMist for self- or caregiver-administration. FluMist is authorized for the prevention of influenza in those ages 2 to 49 who are…
ImportantThe U.S. Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Niemann-Pick disease, type C (NPC). Miplyffa, in combination with the enzyme inhibitor…
ImportantThe European Medicines Agency (EMA) has suggested expanding the use of the Imvanex smallpox and mpox vaccine to adolescents between the ages of 12 and 17. Evaluation of…
FeaturedMHRA launches a new strategy aims to transform the way we provide information on the risks and safety of medicines and medical devices. The Medicines and Healthcare products…
FeaturedFollowing a thorough review, the Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that the available evidence does not establish a causal relationship between Glucagon-Like Peptide-1 (GLP-1)…
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