FDA Approval

Halozyme Announces Takeda Received European Commission Approval for HYQVIA® Co-formulated with ENHANZE® as Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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Halozyme Announces Takeda Received European Commission Approval for HYQVIA® Co-formulated with ENHANZE® as Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Halozyme Therapeutics, Inc. (NASDAQ: HALO) (“Halozyme”) today announced that Takeda received European Commission (EC) approval for HYQVIA® [Immune Globulin...

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Olverembatinib Included in Newest Guidelines on Chronic Myeloid Leukemia (CML) Management from the National Comprehensive Cancer Network (NCCN)

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Olverembatinib Included in Newest Guidelines on Chronic Myeloid Leukemia (CML) Management from the National Comprehensive Cancer Network (NCCN)

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B...

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Acurx Announces Positive Comparative Microbiology and Microbiome Data for Ibezapolstat from Phase 2b Clinical Trial in CDI Patients

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Acurx Announces Positive Comparative Microbiology and Microbiome Data for Ibezapolstat from Phase 2b Clinical Trial in CDI Patients

Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) (“Acurx” or the “Company”), a late-stage biopharmaceutical company developing a new class of...

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U.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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U.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Takeda today announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA® [Immune Globulin Infusion 10%...

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Endovascular Engineering’s Hēlo™ Thrombectomy System Receives IDE Approval to Start ENGULF Pivotal Trial for the Treatment of Pulmonary Embolism

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Endovascular Engineering’s Hēlo™ Thrombectomy System Receives IDE Approval to Start ENGULF Pivotal Trial for the Treatment of Pulmonary Embolism

Endovascular Engineering (“E2”), a medical device company focused on the development and deployment of groundbreaking clot removal...

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Calliditas refinances existing term loan with Euro 92 million senior secured facility with Athyrium Capital

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Calliditas refinances existing term loan with Euro 92 million senior secured facility with Athyrium Capital

Calliditas Therapeutics AB (Nasdaq: CALT) and (Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the company has signed and fully drawn...

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NRx Pharmaceuticals Announces Signing of a Data and Technical Information Agreement with Columbia University Accessing Key Data Demonstrating Efficacy and Safety of Intravenous Ketamine for the Treatment of Suicidal Depression

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NRx Pharmaceuticals Announces Signing of a Data and Technical Information Agreement with Columbia University Accessing Key Data Demonstrating Efficacy and Safety of Intravenous Ketamine for the Treatment of Suicidal Depression

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”, the “Company”), a clinical-stage biopharmaceutical company, today announced that it has...

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WAINUA™ (eplontersen) granted regulatory approval in the U.S. for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis

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WAINUA™ (eplontersen) granted regulatory approval in the U.S. for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis

Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved Ionis and...

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Vaccine Partner Valneva receives FDA approval for the World’s first chikungunya vaccine using Albumedix’ Recombumin®

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Vaccine Partner Valneva receives FDA approval for the World’s first chikungunya vaccine using Albumedix’ Recombumin®

The FDA on 10th November 2023 announced the approval of IXCHIQ®, Valneva’s vaccine against the chikungunya virus. Notably, this is...

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Neuspera Medical, Inc. Announces Milestone Completion of 100th Implant in Its SANS-UUI Phase II Clinical Trial

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Neuspera Medical, Inc. Announces Milestone Completion of 100th Implant in Its SANS-UUI Phase II Clinical Trial

Neuspera Medical, Inc., a neuromodulation company pioneering the Neuspera Implantable Sacral Neuromodulation (SNM) System, today announced the completion...

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