Newsroom
300 articles
Featured Cobenfy (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…
Important EMA’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…
Featured The 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…
Featured The 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…
Important The 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…
Important The 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…
Featured MHRA 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…
Featured Following 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)…
Featured EMA’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…
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…
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