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SIBIONICS Launches the Breakthrough SIBIO KS1 CKM for Ketone Level Monitoring
Boasting CE certification for wearable biosensors for monitoring healthcare, the KS1 is the world’s first all-in-one sensor and transmitter that provides real-time monitoring for ketone diet practitioners
AbbVie’s Aquipta secures MHRA marketing nod to prevent migraines
The authorisation was based on the findings from two Phase 3 trials in which the treatment met their primary endpoint of a change from baseline in mean monthly migraine days across 12 weeks compared to placebo
Orion Health launches Virtuoso DFD technology to enhance healthcare experience
Orion Health’s DFD is designed to help people in their healthcare journey whilst supporting health systems’ existing constraints in care delivery like increasing costs and healthcare worker burnout
Cipla Medpro South Africa to acquire Actor Pharma
This is a strategic acquisition for Cipla South Africa to unlock the future growth opportunities and leverage cost synergies in the South African market
Japan’s MHLW accepts GSK’s sJNDA for Nucala to treat CRSwNP in adults
The sJNDA is based on the data from the Phase 3 MERIT trial that examined the efficacy and safety of Nucala over 52 weeks and the Phase 3 SYNAPSE study which examined the impact of mepolizumab versus placebo
China’s NMPA approves AstraZeneca’s Calquence for lymphocytic leukaemia
The approval was based on the findings from the ASCEND global Phase 3 trial and a Phase 1/2 local trial, which demonstrated an 83.3% overall response rate in Chinese patients treated with Calquence
Hugel resubmits BLA for botulinum toxin Letybo to FDA for glabellar lines
Letybo is a product in the Korean botulinum toxin market that has successfully entered global markets like China, Europe, and Australia, becoming the first Korean toxin brand to be introduced
Roche’s Alecensa delivers unprecedented Phase III results for people with ALK-positive early-stage lung cancer
ALINA data demonstrate Alecensa reduces disease recurrence in the early setting for people with ALK-positive non-small cell lung cancer (NSCLC), building on its long-established benefit in the advanced setting
Alcresta Therapeutics Announces FDA Expanded Use Clearance for RELiZORB Cartridge for Pediatric Patients Ages 2 to 5 Years
RELiZORB is the only enzyme product cleared by the FDA for use with enteral feeding
ACTIMIS Post-hoc Results on Imaging Stroke Data Using Artificial Intelligence Reinforces Glenzocimab Mode of Action in Stroke Patients
The ACTIMIS clinical trial evaluating glenzocimab in combination with the reference treatment in patients presenting with AIS has demonstrated a favorable safety profile of glenzocimab, as well as a significant reduction in the number of intracerebral hemorrhages and mortality in the group treated with glenzocimab