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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…

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…

The U.S. Food and Drug Administration approved Zurnai, the first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose in adults and…

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…

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…

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…

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…