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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


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


Cosmo and Glenmark receives market authorization of Winlevi in Europe
News | November 23, 2025

Cosmo and Glenmark receives market authorization of Winlevi in Europe

Winlevi is authorized in EU for the treatment of acne vulgaris


FDA approves combo therapy for Cisplatin-ineligible muscle-invasive bladder cancer patients
Drug Approval | November 23, 2025

FDA approves combo therapy for Cisplatin-ineligible muscle-invasive bladder cancer patients

The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy