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307 articles
FeaturedThe new UK–US partnership will harness joint expertise in evolving technologies to deliver real-world benefits, from accelerating drug discovery with AI and quantum computing to provide patients with…
FeaturedThe Food & Drug Administration has just launched the final guide for Good Clinical Practice Guidance E6(R3). The updated guideline introduces flexible, risk-based approaches to trial design and…
FeaturedThe FDA has just released updated guidance on biosimilar development a big move for manufacturers navigating this space. The update proposes improved clarity, especially around patient safety and…
FeaturedOn the 10th of September, the FDA approved KOSELUGO (selumetinib) granules & capsules for children 1 year or older who suffer from neurofibromatosis type 1 (NF1) and who…
FeaturedImmune thrombocytopenia an autoimmune disease known for having decreased platelets count which in turn results in frequent bruising & bleeding due to loss of clot formation ability. Patients…
FeaturedIn coordination with the State Office for Health and Social Affairs Berlin (LAGeSo), Esteve Pharmaceuticals GmbH has reported regarding the presence of particles in some of the vials…
FeaturedOn the 21st of May Roche has identified a mistake in Evrysdi product labelling statement & SmPC as they found out it was missing out the point related…
FeaturedWith FDA’s continuous efforts to provide high standard healthcare system comes the next step of providing a fast adverse reporting system, this milestone reflects a pivotal advancement in…
FeaturedThe Kingdom of Saudi Arabia has been working nonstop towards providing better healthcare solutions, keeping their promise of enhancing the healthcare sector as part of the Saudi Vision…
FeaturedThe opioid epidemic, where almost one million Americans died due to improper use of opioids. Leading to the implementation of strict rules & changes in the labeling guide…
FeaturedPeople suffering from BCG-unresponsive non-muscle invasive bladder cancer now have a new hope with the recent approval of the Medicines and Healthcare Products Regulatory Agency (MHRA) of the…
FeaturedThe Medicines and Healthcare Products Regulatory Agency (MHRA) granted approval for EURneffy, the first intranasal adrenaline (epinephrine) treatment for emergency management of anaphylaxis, offering a needle-free alternative to…
FeaturedElinzanetant (Lynkuet) finally getting MHRA approval to provide relief for women suffering from menopausal symptoms. With Elinzanetant being the first non-hormonal therapy of its kind, works by modulating…
FeaturedThe FDA just recently placed investigational measures on Sarepta Therapeutics new medication “Elevidys” that has been indicated for treatment patients suffering from Duchenne muscular dystrophy (DMD), after alarming…
FeaturedAfter deep review the EMA’s safety committee (PRAC) has decided on stopping the temporary restriction of people aged 65 years or older from getting the chikungunya vaccine. Nevertheless,…
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