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

Telangana fires up biologics innovation, debuts India's first single-use bioprocess scale-up hub

The State’s PPP model has already mobilised Rs. 150 crore in core infrastructure, while Thermo Fisher has invested Rs. 90 crore in the Bioprocess Design Centre and its co-located Customer Experience Centre

Novo Nordisk’s Semaglutide fails to slow Alzheimer’s progression in Phase 3 trials

The trials, designed to assess whether semaglutide could slow cognitive decline, showed no significant difference compared to placebo in the progression of Alzheimer’s disease over two years

Alzheimer’s testing goes painless, homebound with Neurogen-Tasso partnership

The collaboration aims to make Alzheimer’s biomarker testing more accessible and less intimidating

NATCO Pharma receives 7 observations from USFDA for API unit at Manali

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

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

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

FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer

HER2-mutant NSCLC typically has a poor prognosis and limited treatment options

AbbVie’s EPKINLY gains FDA nod for relapsed follicular lymphoma, offering new hope for patients

The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study