breakthrough designation
Novartis presents positive results from two phase 3 trials for relapsing MS
Remibrutinib reduced relapse rates and improved disease progression rates
Roche announces phase 3 results for KRAS G12C-mutated non-small cell lung cancer
The Krascendo 1 study showed improved survival rates of 18 months compared to 12 months with current standard of care
Roche’s fenebrutinib receives FDA filing acceptance for relapsing and primary progressive MS
If approved, this treatment would offer a new option for the nearly one million Americans living with MS
Novartis’ Cosentyx gets positive CHMP opinion for polymyalgia rheumatica
If approved, this would be the first IL-17A inhibitor licensed in Europe for adults with polymyalgia rheumatica
Roche and Dualitas Therapeutics announce research collaboration worth up to $1bn
The two companies aim to discover and develop novel bispecific antibodies for immunology and inflammation diseases
Roche’s Enspryng gets FDA Priority Review for autoimmune disease with no approved treatments
MOGAD, a rare disease of the central nervous system, can attack optic nerves, the spinal cord and the brain
FDA approves Priovant’s Lisraya for dermatomyositis
This is the first oral drug treatment for this rare disease in adults
AstraZenca’s Etcamah combination therapy given FDA Accelerated Approval for breast cancer
The approval was based on phase 3 trial results showing a 56% risk reduction in disease progression
Pfizer and BioNTech’s XFG-adapted COVID-19 vaccine approved by US FDA
The 2026-2027 vaccine targets the XFG variant to more closely match current variants
Novartis announces trial results for remibrutinib in relapsing multiple sclerosis
MS affects nearly three million people worldwide and has three main types
FDA grants Fast Track status for peanut allergy immunotherapy
The treatment uses peptides designed to retrain the immune system to tolerate peanuts
Novartis’ Pluvicto approved by FDA for metastatic hormone-sensitive prostate cancer
More than 186,000 men are diagnosed each year with mHSPC globally