Rhapsido doubles complete hive response rate as Novartis secures new FDA indication
FDA approves Novartis Rhapsido as the first treatment specifically for symptomatic dermographism after positive Phase III RemIND results.
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
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
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
FDA sets January decision for Pharming Group’s lower-dose Joenja pediatric expansion
FDA grants Priority Review to lower-dose Joenja for children with APDS weighing 13–27 kg, setting a January 30, 2027 decision date.
Features & Analysis
Relay handed Lyrfigtu to Elevar for $5m upfront. FDA approval now tests the value of that unusual biotech deal
The FDA has approved Elevar Therapeutics’ Lyrfigtu for previously treated FGFR2-rearranged cholangiocarcinoma after a 46% response rate and 11.8-month median response duration. The drug enters an established targeted market, making FGFR2 selectivity, tolerability, molecular testing and eventual activity against resistance mutations more important than simply being another approved inhibitor.
Pharma & Biotech
Miv-cel sustains one-year SPS benefit as Kyverna advances CAR T therapy toward FDA filing
Kyverna’s miv-cel sustains mobility gains and keeps 92% of SPS patients off chronic immunotherapy at one year as its FDA filing advances.
Features & Analysis
Long-acting ORKA-001 maintains deep psoriasis responses as Phase 3 planning approaches
ORKA-001 reaches 71.4% complete psoriasis clearance at Week 28 without redosing. See what the data mean for Oruka’s long-acting biologic strategy.
Pharma & Biotech
Roche reports positive Phase III sefaxersen results as factor B competition intensifies in IgA nephropathy
Roche’s sefaxersen hits its Phase III IgAN endpoint with significant proteinuria reduction. See what the result means for regulators and competitors.