FDA

Key TakeawaysThe FDA clearance enables Ariceum Therapeutics to commence Phase I/II trials for 225Ac-SSO110. The trial will focus on treating small cell lung...

Key TakeawaysThe FDA approval of JYLAMVO now includes paediatric indications for ALL and pJIA. JYLAMVO offers a patient-friendly, orange-flavored oral liquid solution. The...

Key TakeawaysVGA039, Star Therapeutics' investigational monoclonal antibody, receives Fast Track designation for von Willebrand disease (VWD). VGA039 is potentially the first subcutaneous therapy...

Key TakeawaysFDA grants tentative approval for Lasix ONYU, a combination of furosemide and an innovative on-body delivery device. Gerresheimer developed the device with...

Key TakeawaysTRYNGOLZA™ (olezarsen) becomes the first FDA-approved treatment for familial chylomicronemia syndrome (FCS). Demonstrated significant triglyceride reduction and decreased acute pancreatitis events in...

Key TakeawaysInogen’s FDA clearance positions the company competitively within the respiratory care market. The SIMEOX 200’s innovative technology addresses specific needs of patients...

Key TakeawaysOpdivo Qvantig offers faster subcutaneous administration compared to intravenous treatments. Phase 3 trials confirmed efficacy and comparable safety to IV Opdivo. This...

Key TakeawaysONWARD Medical's ARC-EX System receives FDA approval as the first non-invasive therapy for spinal cord injuries. The system significantly improves hand strength...

Key TakeawaysWRAPSODY's approval may reduce the frequency of invasive procedures for dialysis access maintenance. Enhanced vessel patency could lead to increased patient survival...

Key Takeaways • Ryoncil provides a new treatment option for children suffering from SR-aGVHD • Demonstrates significant response rates in clinical trials • Addresses unmet medical needs...

Key TakeawaysThe FDA is intensifying its crackdown on unauthorized pharmaceutical distributions to protect consumer health. New EU import regulations reflect a broader commitment...

Key TakeawaysInnoviva aims to strengthen its presence in the critical care market through strategic acquisitions. Zevtera’s unique FDA approval provides a competitive advantage...

Key Takeaways • VTAMA cream offers an effective treatment alternative for adults and children as young as two. • Patients experience rapid itch relief and sustained...

Key TakeawaysImpella pumps reduce ventricular workload, promoting heart recovery in critical pediatric cases. Expanded indications cover a broader range of heart failure etiologies,...

Key TakeawaysDatopotamab deruxtecan addresses a critical gap in treatment options for EGFR-mutated NSCLC patients. Early trial results indicate a substantial improvement in response...