Can Immutep Limited convert orphan designation into a credible late-stage oncology program?
FDA orphan drug designation gives Immutep Limited a new sarcoma pathway. Find out why eftilagimod alfa could reshape its oncology strategy.
What Grace Therapeutics’ STRIVE-ON data may change in neurocritical care
Grace Therapeutics’ GTx-104 heads to AAN 2026 just before FDA decision day. Find out what this could change in neurocritical care.
How Telix Pharmaceuticals Limited may be building a stronger neuro-oncology diagnostics franchise
Telix Pharmaceuticals Limited’s TLX101-Px NDA has been accepted by the FDA. Discover what this means for glioma imaging and the September decision.
Why the latest Merakris Therapeutics data may sharpen industry focus on refractory wound healing
Read why Merakris Therapeutics’ MTX-001 data may sharpen industry focus on refractory wound healing and reshape the late-stage wound care outlook.
How Cogent Biosciences, Inc.’s bezuclastinib filing could redefine the second-line treatment paradigm in gastrointestinal stromal tumors
Cogent Biosciences files bezuclastinib NDA in second-line GIST. Explore what the PEAK data could change for clinicians, regulators, and investors.
Why Incyte’s povorcitinib 54-week results matter for hidradenitis suppurativa treatment
Incyte’s povorcitinib reaches 71.4% HiSCR50 at 54 weeks in HS. Analysis of what the STOP-HS data mean for the JAK1 class and the treatment landscape.
How Agilent’s PD-L1 companion diagnostic now shapes pembrolizumab access in esophageal carcinoma
FDA approves Agilent’s PD-L1 IHC 22C3 pharmDx for esophageal and GEJ carcinoma, marking the eighth companion diagnostic indication alongside pembrolizumab. Read the analysis.
IntraBio leverages prior Niemann-Pick approval to seek FDA expansion of levacetylleucine into Ataxia-Telangiectasia
IntraBio files the first-ever FDA application for an A-T therapy. Analyse the Phase III evidence, regulatory pathway, and what approval would mean.
Guardant Health brings Shield multi-cancer detection test to Asia through Manulife insurer deal
Guardant Health partners with Manulife to launch its Shield MCD blood test in Hong Kong, Singapore and the Philippines. Analysis of what this means for oncology.
United Therapeutics targets 2026 FDA submission for Tyvaso IPF indication after TETON-2 success
TETON-2 phase 3 data show nebulized treprostinil slows IPF lung decline and cuts clinical worsening risk. Analysis of what the NEJM results mean.