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307 articles
ImportantThe European Medicines Agency (EMA) is responsible for coordinating scientific evaluation, supervision, and safety monitoring of medicines in the European Union (EU). The EMA’s Health Threats Plan outlines…
ImportantThe 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)…
WarningsThe U.S. Food and Drug Administration (FDA) has approved significant safety updates for Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for Duchenne muscular dystrophy (DMD). The updated labeling now…
Trending topicsThe U.S. Department of Health and Human Services (HHS) today took a historic step to bring evidence-based science back to women’s health. Following over 20 years of fear…
Trending topicsA recent study carried out by UK’s Medicines and Healthcare products Regulatory Authority (MHRA) has revealed a huge variability in research methods associated with microbiome studies performed internationally.…
Drug ApprovalsThe Medicines and Healthcare products Regulatory Agency (MHRA) has revealed plans to overhaul the regulatory framework for rare disease therapies, aiming to speed up their development and availability…
WarningsChildren and young adults, particularly university students, remain at risk from meningococcal meningitis and septicaemia, conditions that, while rare, can be devastating, life-changing, and sometimes fatal. Latest data…
ImportantThe 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…
Trending topicsThe Saudi Food and Drug Authority (SFDA) has launched the Regulatory AI System for Incoming Drugs (RASID), a smart service utilizing artificial intelligence to regulate controlled medications carried…
WarningsDamaged capsules have been identified in batches of Lenalidomide Mylan, with powder visible inside the blister pocket. For all strengths and pack sizes, healthcare professionals should carefully inspect…
Drug ApprovalsOn October 24, 2025, the U.S. Food and Drug Administration approved Revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for adult and pediatric patients aged 1 year and…
Drug ApprovalsOn October 23, 2025, the FDA approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a targeted B-cell maturation antigen (BCMA) antibody-drug conjugate, in combination with bortezomib and dexamethasone (BVd) for adults…
Drug ApprovalsOn October 24, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) approved Concizumab (Alhemo) to prevent or reduce the frequency of bleeding episodes in people aged 12…
Trending topicsThe Saudi Food and Drug Authority (SFDA), led by CEO Dr. Hisham S. Aljadhey, has launched the Electronic Integration of Medications Risk Minimization Measures (RMMs) with several prominent…
ImportantThe 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…
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