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

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

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

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

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

Desai is currently serving the company as Group Finance Controller

Aayush Wellness partners with Blinkit to strengthen distribution network

The partnership will enable rapid and reliable product delivery

Cosmo and Glenmark receives market authorization of Winlevi in Europe

Winlevi is authorized in EU for the treatment of acne vulgaris

Solara’s Mangalore facility clears FDA inspection with VAI status

Biocon Pharma gets FDA nod for arthritis drug Tofacitinib ER

Tofacitinib extended-release tablets are a Janus kinase inhibitor indicated for Rheumatoid Arthritis