The FDA’s review also revealed delays in Philips’ internal investigations, with 54 inquiries failing to meet targeted completion dates—23 of which were delayed by more than 100 days
Approval based on pivotal KOMET Phase III trial demonstrating significant tumour reduction in adults with NF1
Key secondary endpoints also demonstrated statistically significant and clinically meaningful benefits with Gazyva
Quest Diagnostics’ blood-based test panels demonstrate confirmatory accuracy, potentially reducing the need for PET imaging
Sotyktu continues to demonstrate consistent efficacy and safety across rheumatic conditions
Results demonstrate favorable safety profile and clinically meaningful improvements in patients with non-ischemic heart failure
Advancing toward Phase 2a evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast Track designation
Medherant’s testosterone TEPI Patch could become the first-in-class testosterone patch developed specifically for women
Long-term OGSIVEO treatment for up to four years associated with further tumor reductions, increased objective response rate, sustained symptom improvement, and consistent safety profile
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