Newsroom
79 articles
Important The U.S. Food and Drug Administration (FDA) has issued important guidance for generic drug manufacturers seeking waivers for differences in pH adjusters compared to reference listed drugs (RLDs)…
Important The Saudi Food and Drug Authority (SFDA) has launched the National Network for Drugs and Medical Products Safety During Pregnancy and Breastfeeding. Unveiled at the Global Health Exhibition…
Important The CEO of the Saudi Food and Drug Authority (SFDA), Dr. Hisham S. Aljadhey, has introduced the Saudi Pharmacopoeia at the Global Health Exhibition in Riyadh (Held from…
Important The UK’s Innovative Licensing and Access Pathway (ILAP) aims to help patients get promising and much-needed new medicines more quickly. Announced by the Medicines and Healthcare products Regulatory…
Important Eisai GmbH, in agreement with the European Medicines Agency (EMA), has updated the MRI monitoring schedule for LEQEMBI (lecanemab) 100 mg/mL concentrate for infusion, a treatment for early…
Important The SFDA launched a dedicated webpage on its website that provides access to draft guidelines under development for public consultation and private sector feedback, along with the officially…
Important The Medicines and Healthcare products Regulatory Agency (MHRA), alongside the Advertising Standards Authority (ASA) and the General Pharmaceutical Council (GPhC), has issued an updated Enforcement Notice clarifying rules…
Important The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that there is no evidence linking paracetamol use during pregnancy to autism in children. Dr Alison Cave, Chief…
Important Opioid misuse continues being a challenge in the United States, with it being prescribed to about 1 in 5 U.S adults who struggle with chronic pain & which…
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…
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…
Important 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 pediatric patients…
Important 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. Tell patients to…
Important 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 are…
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