Novartis scores FDA nod for game-changing SMA treatment

Itvisma is a one-time, fixed-dose therapy designed to tackle the genetic root cause of SMA

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

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

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

Alvotech and Advanz Pharma secure European nod for Gobivaz, first biosimilar to Simponi

Gobivaz is authorised for adults with rheumatoid arthritis (in combination with methotrexate), psoriatic arthritis (with or without methotrexate), axial spondyloarthritis, and ulcerative colitis

FDA nod to Koselugo for adults with Rare NF1 tumors, expanding life-changing treatment

Meduloc wins FDA green light for new class of bone-fracture fixation system

The cleared system pairs a flexible nitinol implant with a deployable prong-locking mechanism, delivering rotational and length stability

WHO issues first global guidelines for managing diabetes in pregnancy

Uncontrolled diabetes in pregnancy dramatically increases the risk of pre-eclampsia, stillbirth, birth injuries, and long-term cardiometabolic diseases

BASF and Beyond Suncare welcome WHO decision to list broad-spectrum sunscreen as “Essential Medicine”

The inclusion of broad-spectrum sunscreen in the WHO EML and EMLc follows an application submitted in November 2024 by the Global Albinism Alliance

Glenmark secures China approval for Ryaltris

The approval granted with zero supplementation requests is an important milestone in Glenmark’s respiratory pipeline