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FRONTIER4 extension study demonstrates sustained safety, low bleeding rates and flexible dosing across children, adolescents and adults, while new data on concizumab highlights reduced bleeding episodes in pediatric patients with hemophilia.
Clinical Data | 13/07/2026 | By News Bureau
US FDA Issues Complete Response Letter for Ascelia Pharma's Orviglance NDA
Ascelia Pharma has received a Complete Response Letter from the US FDA for its New Drug Application for Orviglance, prompting the company to seek further regulatory discussions while reaffirming its commitment to advancing the rare oncology therapy.
Clinical Data | 06/07/2026 | By News Bureau | 225
Belief Pharmaceuticals' Haemophilia B Gene Therapy Approved in Macau
Macau approves Belief Pharmaceuticals’ Popedacoq gene therapy for haemophilia B, marking regional expansion after China approval and advancing access to one-time treatment solutions.
Clinical Data | 23/03/2026 | By News Bureau
FDA Acknowledges Pain Reduction Data Supporting Rexlemestrocel-L Efficacy
The US Food and Drug Administration (FDA) has acknowledged clinical data showing that Rexlemestrocel-L reduced pain intensity over 12 months, supporting the product’s efficacy in treating back pain. The agency also indicated that the approval label may include language related to opioid reduction.
Clinical Data | 19/01/2026 | By News Bureau | 156
Sun Pharma Presents Two Posters on Utreglutide at ObesityWeek 2025
Sun Pharma presented new clinical data on its investigational GLP-1 agonist, Utreglutide, at ObesityWeek 2025, highlighting meaningful reductions in body weight, waist circumference, and lipid parameters across two studies, with the therapy showing a favourable and class-consistent safety profile.
Clinical Data | 14/11/2025 | By Dineshwori | 424
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