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Home»Posts tagged with»FDA (Page 2)

ROSELLA trial at ASCO 2026: Corcept’s Lifyorli subgroup data and what it means for platinum-resistant ovarian cancer practice

By Pallavi Madhiraju on April 22, 2026   Pharma & Biotech  

ROSELLA trial at ASCO 2026: Corcept’s Lifyorli subgroup data and what it means for platinum-resistant ovarian cancer practice

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.

Can Immutep Limited convert orphan designation into a credible late-stage oncology program?

By Soujanya Ravi on April 15, 2026   Pharma & Biotech  

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

By Soujanya Ravi on April 14, 2026   Pharma & Biotech  

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

By Soujanya Ravi on April 10, 2026   Pharma & Biotech  

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

By Soujanya Ravi on April 7, 2026   Pharma & Biotech  

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

By Soujanya Ravi on April 1, 2026   Pharma & Biotech  

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

By Pallavi Madhiraju on March 30, 2026   Pharma & Biotech  

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

By Pallavi Madhiraju on March 27, 2026   Pharma & Biotech  

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

By Pallavi Madhiraju on March 21, 2026   Pharma & Biotech  

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

By Pallavi Madhiraju on March 17, 2026   Medical Devices & Diagnostics  

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.

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