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FeaturedEvrysdi (risdiplam): Omission in EU Product Labeling Identified
On 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…
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FeaturedFrom Delayed to Instant: FDA Opens Real-Time Window on Drug Safety
With 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…
FeaturedNew SFDA Approval Brings Diagnostic Devices for Antipsychotic Blood Monitoring
The 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…
FeaturedFDA Tightens Opioid Labeling Rules to Guide Safer Use
The 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…
FeaturedMHRA Expands Bladder Cancer Treatment Choices with Latest Approval
People 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…
FeaturedFirst Ever Allergic Shock Treatment in Nasal Spray Form
The 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…
FeaturedMHRA Greenlights New Treatment for Menopausal Symptoms
Elinzanetant (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…
FeaturedFDA Suspends Elevidys Distribution and Trials Following Safety Concerns
The 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…
FeaturedReinforcing Precautions: Ixchiq Vaccine and Immunocompromised Patients
After 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,…
FeaturedFDA Grants Fast-Track Approval to Linvoseltamab-GCPT for Advanced Multiple Myeloma
On July 2, 2025, the FDA gave accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals, Inc.), a targeted therapy that helps the immune system attack cancer cells. It is…
FeaturedPrecision Meets Innovation: SFDA Endorses Real-Time Brain Stimulation Technology for Parkinson’s Disease
The Saudi food & drug authority has been actively working towards advancing public health in kingdom through ongoing strategic initiatives aimed at strengthening the healthcare system with the…
FeaturedFDA Warns: Weight Loss Risk in Young Children on ADHD Medications
Based on recent FDA findings the use of extended-release stimulants for ADHD management in children below 6 years old has been causing weight loss & other adverse events…
FeaturedOne Gate, Less Wait: New Rules for Radiation Protection in Clinical Trials
As of 1st of July 2025 regulations associated with the use of radioactive substances or ionizing radiation has changed to ease the process for applications in order to…
FeaturedBreaking Ground in small cell lung cancer: First Anti-PD-1 Antibody Gains UK Approval
Patients fighting extensive stage small cell lung cancer (SCLC) now have new hope with UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently approving serplulimab (Hetronifly) a PD-1…
FeaturedNew Hope for Fatty Liver: Tackling Scarring Head-On
The European Medicines Agency (EMA) has suggested granting provisional marketing authorization for Rezdiffra (resmetirom) the first treatment in the EU for noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with modest…
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