How Rhapsido’s symptomatic dermographism approval expands Novartis immunology strategy
Novartis’ Rhapsido won the first FDA label for symptomatic dermographism after a 29.3% complete response in Phase 3 RemIND.
Pharma & Biotech
Pharma & Biotech
SurVaxM showed a four-month survival gap in younger glioblastoma patients. Can MimiVax overcome the missed primary endpoint?
MimiVax and Roswell Park reported a 2.5-month median overall-survival difference for SurVaxM in the 233-patient SURVIVE trial, but the full-population primary endpoint did not reach statistical significance. A prespecified group aged 65 or younger showed a stronger and statistically significant survival result, leaving the FDA to assess whether the signal is sufficient to define the
Pharma & Biotech
argenx halts Phase 3 efgartigimod Sjögren’s trial after futility analysis
argenx stops the Phase 3 UNITY efgartigimod trial in Sjögren’s disease for futility despite earlier positive Phase 2 results.
Pharma & Biotech
Can Roche’s petrelintide challenge GLP-1 drugs after strong obesity and diabetes data?
Zealand Pharma and Roche have reported positive Phase 2 data for petrelintide in people with obesity and type 2 diabetes, combining up to 9.2% weight loss with improved glycemic control and a low gastrointestinal discontinuation rate as the amylin therapy enters a roughly 7,000-patient Phase 3 program.
Pharma & Biotech
Pfizer takes Tukysa into first-line HER2+ breast cancer maintenance after 8.6-month PFS gain
FDA approval moves Pfizer’s Tukysa into first-line maintenance for HER2-positive metastatic breast cancer after the regimen extended median progression-free survival from 16.3 to 24.9 months, although severe hepatotoxicity has emerged as an important treatment consideration.
Pharma & Biotech
Oral infigratinib moves toward FDA decision after positive PROPEL 3 trial
FDA grants Priority Review to oral infigratinib after positive PROPEL 3 achondroplasia results, setting a February 4, 2027 decision.
Pharma & Biotech
Firmonertinib misses pivotal endpoint as investigator and independent PFS results diverge
Firmonertinib misses the FURVENT Phase 3 PFS endpoint in EGFR exon 20 insertion NSCLC despite stronger response and investigator-assessed results.
Pharma & Biotech
FDA clears digital therapeutic Motivista after positive Phase III schizophrenia trial
FDA clears Click Therapeutics’ Motivista, the first treatment specifically authorized for negative symptoms of schizophrenia.
Pharma & Biotech
BBP-418 Phase 3 analysis adds cardiac signal to positive LGMD2I/R9 efficacy package
BridgeBio reports new BBP-418 cardiac data in LGMD2I/R9 as the oral therapy approaches a November 27 FDA decision.
Pharma & Biotech
Roche cuts MS relapses up to 58.5% with fenebrutinib as FDA weighs an oral rival to its own Ocrevus
The FDA has accepted Roche’s fenebrutinib filing under Priority Review for both relapsing and primary progressive multiple sclerosis, potentially creating a high-efficacy oral alternative across disease forms currently treated very differently.