Home » Posts tagged with» FDA (Page 2)
By Pallavi Madhiraju on April 22, 2026
Pharma & Biotech
Corcept presents Lifyorli ROSELLA phase 3 overall survival data by prior taxane use at ASCO 2026. What the subgroup analysis means for prescribers, payers, and the EMA review. Read now.
By Soujanya Ravi on April 15, 2026
Pharma & Biotech
FDA orphan drug designation gives Immutep Limited a new sarcoma pathway. Find out why eftilagimod alfa could reshape its oncology strategy.
By Soujanya Ravi on April 14, 2026
Pharma & Biotech
Grace Therapeutics’ GTx-104 heads to AAN 2026 just before FDA decision day. Find out what this could change in neurocritical care.
By Soujanya Ravi on April 10, 2026
Pharma & Biotech
Telix Pharmaceuticals Limited’s TLX101-Px NDA has been accepted by the FDA. Discover what this means for glioma imaging and the September decision.
By Soujanya Ravi on April 7, 2026
Pharma & Biotech
Read why Merakris Therapeutics’ MTX-001 data may sharpen industry focus on refractory wound healing and reshape the late-stage wound care outlook.
By Soujanya Ravi on April 1, 2026
Pharma & Biotech
Cogent Biosciences files bezuclastinib NDA in second-line GIST. Explore what the PEAK data could change for clinicians, regulators, and investors.
By Pallavi Madhiraju on March 30, 2026
Pharma & Biotech
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.
By Pallavi Madhiraju on March 27, 2026
Pharma & Biotech
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.
By Pallavi Madhiraju on March 21, 2026
Pharma & Biotech
IntraBio files the first-ever FDA application for an A-T therapy. Analyse the Phase III evidence, regulatory pathway, and what approval would mean.
By Pallavi Madhiraju on March 17, 2026
Medical Devices & Diagnostics
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.