Solengepras delivers positive ARISE Phase 3 results as Cerevance prepares for FDA talks
Cerevance’s solengepras cuts Parkinson’s OFF time and improves daily motor function in a positive Phase 3 trial ahead of FDA discussions.
Features & Analysis
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.
Medical Devices & Diagnostics
Abbott’s CardioMEMS app approval brings heart pressure data directly to patients
Abbott Laboratories (NYSE: ABT) has received United States Food and Drug Administration approval for new patient-facing capabilities within its CardioMEMS HF System, allowing care teams to give patients access to pulmonary artery pressure trends through the CardioGuide HF App. The update also introduces a Dynamic Treatment Plan feature through which clinicians can communicate personalised medication
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.
Pharma & Biotech
NewAmsterdam Pharma and Menarini win EU approval for Ubeslo and Evlarco
NewAmsterdam Pharma Company N.V. and Menarini Group have secured European marketing authorisations for Ubeslo and Evlarco, turning obicetrapib into a commercial-stage cholesterol therapy while leaving PREVAIL to answer the more consequential question of whether its LDL reductions translate into fewer cardiovascular events.
Pharma & Biotech
AMT-130 four-year data extend Huntington’s disease signal as FDA evaluates uniQure BLA
uniQure reports four-year ifezuntirgene data showing slower Huntington’s disease progression as its gene therapy BLA moves through FDA review.
Pharma & Biotech
Novo Nordisk bets up to $2.6bn on Hengrui’s once-weekly oral GLP-1/GIP drug
Novo Nordisk licenses Hengrui’s once-weekly oral GLP-1/GIP candidate HRS-1596 in a deal worth up to $2.6 billion.