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Intelligent Bio Solutions Starts Clinical Program For FDA Clearance Of Codeine Test, Launches Trials With Cliantha To Support U.S. Market Clearance
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Immix Biopharma’s CAR-T Candidate NXC-201 Earns FDA Breakthrough Therapy Designation In Relapsed AL Amyloidosis

Vaibhavi M.

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Intelligent Bio Solutions Starts Clinical Program For FDA Clearance Of Codeine Test, Launches Trials With Cliantha To Support U.S. Market Clearance

Intelligent Bio begins clinical studies to support a new FDA 510(k) submission for its fingerprint-based codeine drug test.

Vaibhavi M.

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Immix Biopharma’s CAR-T Candidate NXC-201 Earns FDA Breakthrough Therapy Designation In Relapsed AL Amyloidosis

Immix Biopharma’s CAR-T therapy NXC-201 receives FDA Breakthrough designation for relapsed/refractory AL amyloidosis.

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FDA Grants Breakthrough Status To Biogen’s Litifilimab For Treatment Of Cutaneous Lupus Erythematosus (CLE)

Biogen’s litifilimab receives FDA Breakthrough Therapy Designation for cutaneous lupus, addressing a major unmet need.

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Chugai Seeks Japanese Approval For Tecentriq, Phase III IMvigor011 Data Supports Filing In MRD-Positive Muscle-Invasive Bladder Cancer

Chugai seeks Japan approval to use Tecentriq as adjuvant therapy for MRD-positive muscle-invasive bladder cancer patients.

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