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Home»Posts tagged with»FDA Fast Track

Autobahn’s elunetirom Fast Track win puts bipolar depression back in regulatory focus

By Pallavi Madhiraju on May 27, 2026   Pharma & Biotech  

Autobahn’s elunetirom Fast Track win puts bipolar depression back in regulatory focus

Bipolar depression needs better options. Autobahn’s elunetirom Fast Track status raises the stakes for its Phase 2 readout.

GE HealthCare’s LUMINA trial could test whether manganese MRI contrast is finally ready for the mainstream

By Pallavi Madhiraju on April 23, 2026   Medical Devices & Diagnostics  

GE HealthCare’s LUMINA trial could test whether manganese MRI contrast is finally ready for the mainstream

GE HealthCare has dosed the first patient in its LUMINA trial for mangaciclanol. Read why this MRI contrast milestone could reshape imaging markets.

Gilead targets durable autoimmune remission with $2.18bn Ouro Medicines acquisition

By Pallavi Madhiraju on March 24, 2026   Pharma & Biotech  

Gilead targets durable autoimmune remission with $2.18bn Ouro Medicines acquisition

Gilead Sciences acquires Ouro Medicines for up to $2.18bn, adding BCMA T cell engager gamgertamig to its inflammation pipeline. Analysis of what the deal reveals.

Can targeting CD36 reshape hepatocellular carcinoma immunotherapy? Pilatus Biosciences takes first step

By Pallavi Madhiraju on February 20, 2026   Pharma & Biotech  

Can targeting CD36 reshape hepatocellular carcinoma immunotherapy? Pilatus Biosciences takes first step

Pilatus Biosciences earns FDA Fast Track for PLT012 in liver cancer. Read why CD36 targeting could reshape immunotherapy development.

Why MIRA Pharmaceuticals is targeting chemotherapy-induced nerve pain with Ketamir-2

By Soujanya Ravi on February 3, 2026   Pharma & Biotech  

Why MIRA Pharmaceuticals is targeting chemotherapy-induced nerve pain with Ketamir-2

Find out how MIRA Pharmaceuticals aims to transform CIPN care with Ketamir-2 and why regulators and investors are watching its 2026 development milestones.

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