News | December 02, 2023
USFDA inspection at Alkem Laboratories API manufacturing facility located at Mandva
The company has received Form 483 with three observations
The company has received Form 483 with three observations
A new GSK survey shows a large number of adults do not understand how shingles may be triggered
Accelerating FDA submission and confirming potential to become first approved biologic for this serious disease
First-ever brain chemistry database will allow clinicians to quickly infer brain biomarker data to support the diagnostic process in conditions such as Alzheimer's Disease
Blenrep (belantamab mafodotin) plus BorDex showed statistically significant progression-free survival (PFS) benefit versus daratumumab plus BorDex
Final stage in licensing OVM-200 from Oxford Vacmedix in the UK
This innovative solution comes as an answer to the industry-wide challenges of availability, cost, and dependencies linked to custom and proprietary hardware components
OCEANIC-AF is one trial which evaluates asundexian versus apixaban in patients with atrial fibrillation at risk for stroke within the overall OCEANIC phase III program
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
Phase 3 data expected in the second half of 2024
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