Business, energy, technology, markets and global industry news from Business News Today

orphan drug designation

Pharma & Biotech

Why EMA orphan status gives Zai Lab’s zoci more than a regulatory credibility boost

Find out how Zai Lab’s zocilurtatug pelitecan could reshape DLL3-targeted cancer therapy as development risks remain.

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Pharma & Biotech

Emalex Biosciences advances Tourette syndrome strategy as ecopipam delays relapse in Phase 3 trial

D1 receptor targeting may change Tourette syndrome care. Ecopipam’s Phase 3 data now face the bigger test: regulation and adoption.

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Pharma & Biotech

Is BRC Therapeutics opening a new regulatory lane for cannabinoid-based CRPS therapies?

CRPS has no approved U.S. therapy. BRC-002 now has an FDA path, but proof of safety, efficacy, and dosing discipline still lies ahead.

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Pharma & Biotech

Is Can-Fite BioPharma Ltd. building a differentiated niche in late-line pancreatic cancer therapy

Is Can-Fite BioPharma Ltd. carving a niche in pancreatic cancer? Explore how namodenoson’s Phase 2a data could reshape late-line treatment strategies.

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Pharma & Biotech

What Orion Corporation’s FDA orphan designation for ODM-212 means for mesothelioma treatment innovation

Discover how Orion Corporation’s ODM-212 orphan drug status could reshape mesothelioma treatment and drive innovation in Hippo pathway targeting.

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Pharma & Biotech

What Medicus Pharma Ltd.’s SkinJect application signals for Hedgehog pathway-driven cancers

Discover how SkinJect’s orphan drug bid could reshape Hedgehog-driven cancer treatment. Read what it means for clinicians, regulators, and investors.

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Pharma & Biotech

Could Ampligen become a late-stage pancreatic cancer breakthrough after AIM ImmunoTech’s latest clinical push?

Can Ampligen’s Phase 3 push reshape pancreatic cancer treatment? Read how AIM ImmunoTech’s latest clinical progress could change the oncology outlook.

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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.

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Pharma & Biotech

Can REYOBIQ improve Plus Therapeutics’ path in pediatric high-grade glioma and ependymoma?

Plus Therapeutics won orphan drug designation for REYOBIQ in pediatric malignant gliomas. Read what it changes for CNS cancer development.

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How REYOBIQ’s latest regulatory milestone may reshape the pediatric neuro-oncology landscape

Plus Therapeutics secures orphan designation for REYOBIQ in pediatric malignant gliomas. Read what this means for trials, exclusivity, and market strategy.

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