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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…

Epimax Ointment and Epimax Paraffin-Free Ointment can harm the eyes if used on the face. Do not prescribe these ointments for use on the face.…

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 17 July 2024, approved the medicine vibegron (Obgemsa) to treat the symptoms of overactive bladder…

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 17 July 2024, approved the medicine capivasertib (Truqap) for patients with advanced hormone receptor (HR)…

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new formulation of the medicine ocrelizumab (Ocrevus 920mg solution for injection) to treat relapsing…

The TGA has received reports of serious adverse events in infants and children who have been given compounded wind and colic preparations containing Atropa belladonna (belladonna). We…

Today, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C…

Migraine and antiseizure medication topiramate must no longer be prescribed to women and girls unless they fulfil the requirements of a Pregnancy Prevention Programme. Following a…

Eurneffy (epinephrine) is an alternative to injectable formulations, EMA’s human medicines committee (CHMP) has recommended granting a marketing authorization in the European Union for Eurneffy (epinephrine), the…

EMA has recommended granting a marketing authorisation in the European Union (EU) for Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension (PAH), in combination with other…