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Incyte Wins US FDA Approval for Jakafi XR (Ruxolitinib)
The US Food and Drug Administration (FDA) approves Incyte Corporation’s Jakafi XR (ruxolitinib), a once-daily extended-release tablet for myelofibrosis, polycythemia vera and GVHD, offering consistent day-long exposure.
Lakewood-Amedex Biotherapeutics Reports Promising AMR Data for Nu-3 in Diabetic Foot Ulcer Treatment
Lakewood-Amedex advances Nu-3 as a potential breakthrough topical therapy to combat antibiotic-resistant infections in diabetic foot ulcers.
Arrowhead Pharmaceuticals Wins Australia TGA Approval for REDEMPLO
Arrowhead Pharmaceuticals receives TGA approval for REDEMPLO (plozasiran) in Australia, the first treatment for Familial Chylomicronemia Syndrome (FCS), backed by phase 3 data showing significant triglyceride reduction and lower pancreatitis risk.
Sonire Therapeutics Launches First US Trial of HIFU Therapy for Pancreatic Cancer
Sonire Therapeutics begins US clinical testing of its HIFU platform, aiming to improve outcomes in hard-to-treat pancreatic cancer.
U.S. Food and Drug Administration grants Priority Review and Breakthrough Therapy status to combination therapy showing significant survival benefits in advanced HER2-positive gastric and esophageal cancers.
Vensica Medical Secures US FDA Clearance to Advance Needle-Free OAB Therapy to Phase II
Vensica Medical moves forward with clinical trials of its needle-free drug delivery platform aimed at improving access and patient comfort in overactive bladder treatment.
Parexel Acquires Vitrana to Boost Patient Safety Solutions
Parexel acquires Vitrana to enhance patient safety solutions with an Artificial Intelligence (AI)-enabled platform offering integrated pharmacovigilance, improved efficiency, and stronger regulatory compliance.
Syngene Strengthens Leadership Team with Two Key Appointments
Maninder Kapoor Puri joins Syngene as Chief Human Resources Officer (CHRO) and Abhijit Zutshi as Chief Commercial Officer (CCO)
US FDA Recommends AstraZeneca's TRUQAP for PTEN-Deficient Prostate Cancer
US Food and Drug Administration (FDA) advisory panel backs TRUQAP (capivasertib) with abiraterone and ADT for PTEN-deficient metastatic hormone-sensitive prostate cancer, based on positive phase 3 CAPItello-281 results showing favorable benefit-risk.
Pfizer's ELREXFIO Boosts Progression-Free Survival in Relapsed Multiple Myeloma
Pfizer’s ELREXFIO meets primary endpoint in MagnetisMM-5, showing significant progression-free survival benefit in relapsed/refractory multiple myeloma, with consistent safety and ongoing evaluation of Overall Survival (OS).
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