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FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures
News | November 24, 2025

FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures

Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels


FDA investigates fatal case linked to rare blood disorder drug Adzynma
News | November 24, 2025

FDA investigates fatal case linked to rare blood disorder drug Adzynma

Adzynma, approved for both adults and children with cTTP, is a recombinant enzyme therapy designed to replace the deficient ADAMTS13 enzyme


Moderna bags $1.5 billion 5-Yr loan to boost financial flexibility
News | November 24, 2025

Moderna bags $1.5 billion 5-Yr loan to boost financial flexibility

The non-dilutive financing includes three tranches


Bayer’s experimental stroke drug could reshape secondary stroke prevention
Clinical Trials | November 24, 2025

Bayer’s experimental stroke drug could reshape secondary stroke prevention

Millions of stroke survivors across the world may soon have a new defense


Mesoblast teams with NIH to launch pivotal trial of life-saving cell therapy in adults with severe aGvHD
Clinical Trials | November 24, 2025

Mesoblast teams with NIH to launch pivotal trial of life-saving cell therapy in adults with severe aGvHD

The therapy -- Ryoncil (remestemcel-L-rknd) -- will be tested in adults with severe steroid-refractory acute graft-versus-host disease


Contineum MS drug stumbles in mid-stage trial
Clinical Trials | November 24, 2025

Contineum MS drug stumbles in mid-stage trial

Topline results from the Phase 2 VISTA trial show that PIPE-307 did not meet its primary or secondary efficacy endpoints


Dr Reddy’s receives EU nod for AVT03 biosimilar denosumab
News | November 24, 2025

Dr Reddy’s receives EU nod for AVT03 biosimilar denosumab

AVT03 is a biosimilar of Amgen's Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL), which are used to treat various bone conditions


Hester Biosciences appoints Ashish Desai as CFO
People | November 23, 2025

Hester Biosciences appoints Ashish Desai as CFO

Desai is currently serving the company as Group Finance Controller