Biogen bags FDA nod for high dose SPINRAZA in spinal muscular atrophy

The new regimen, delivering 50 mg/5 mL and 28 mg/5 mL doses, offers a higher concentration of the drug for both loading and maintenance phases

VLCC becomes exclusive partner to offer international laser certification exams in India

This makes VLCC the sole institution in the country authorised to conduct in-person NCLC exams

Investigational therapy efzimfotase alfa shows promising Phase III results in rare bone disease

Efzimfotase alfa is an investigational enzyme replacement therapy designed to reduce injection volume

Bavarian Nordic seeks EMA nod for Mpox vaccine in children aged 2–11

The trial demonstrated that immune responses in children were non-inferior to adults, with a similar safety profile after two standard doses of MVA-BN

Bristol Myers Squibb reports positive phase 4 data on Cobenfy for schizophrenia patients

The open-label trial involved 105 adults with schizophrenia who were on a stable dose of an oral atypical antipsychotic for at least six weeks

Biocytogen partner NEOK Bio gets FDA nod for novel cancer therapy

The investigational new drug application with FDA was actually for NEOK002, an EGFR/MUC1-targeting antibody-drug conjugate aimed at solid tumors

GSK seeks European nod for promising Hepatitis B therapy

ENHERTU approved in China as first HER2-targeted ADC for early breast cancer

The decision is based on the phase 3 DESTINY-Breast11 trial

Teva hits major biosimilar milestones with FDA nod and regulatory filings

The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia

Allergan Aesthetics showcases breakthroughs at AAD 2026

Allergan also presented new insights on the growing population of patients on GLP-1 agonists for weight loss who are seeking aesthetic treatments