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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.…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…