Newsroom
301 articles
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)…
FeaturedEMA’s safety committee, PRAC, has recommended measures to minimize the serious outcomes of agranulocytosis, a known side effect caused by the painkiller metamizole. Agranulocytosis involves a sudden and…
FeaturedThe 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…
FeaturedGuiding 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…
FeaturedThe 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…
FeaturedThe 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…
FeaturedA 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…
Talk to our experts and get tailored solutions to help you stay compliant and move forward with confidence.
Submit RFI/RFP
Request Consultation
Submit RFI/RFP