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

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

The non-dilutive financing includes three tranches

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

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

Neurocrine review highlights key differences between tardive dyskinesia drugs

Rafa Laboratories lands $186 million BARDA contract to develop life-saving trauma drug

Landmark studies have shown that rapid TXA administration can significantly reduce mortality

AstraZeneca to invest $2 billion in Maryland manufacturing expansion

The multibillion-dollar Maryland expansion is part of AstraZeneca’s sweeping $50 billion global investment plan