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Category: Impacting News

The FDA Advisory Committee Will Soon Review the NDA of Amylyx Pharmaceuticals' Product AMX0035 for ALS  

On September 7th the FDA Will Review Amylyx Pharmaceuticals NDA for ALS Treatment Amylyx Pharmaceuticals ( AMLX ) announced that the U.S. FDA Peripheral and Central Nervous System Advisory Committee ( PCNSDAC ) will reconvene to review the New Drug...

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August 11, 2022

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Important Data Will Be Presented by Regenxbio on August 30th

Regenxbio to Present Important Data  Regenxbio ( RGNX ) will present important material at the Society for the Study of Inborn Errors of Metabolism Annual Symposium, taking place in Germany from August 30 through September 2, 2022. The presentations are...

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August 23, 2022

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Atea Pharmaceuticals: The U.S. FDA Granted Fast Track Designation to Bemnifosbuvir Oral Antiviral for COVID-19

Atea Pharmaceuticals Receives Fast Track Designation for Bemnifosbuvir Atea Pharmaceuticals ( AVIR ) announced that the U.S. FDA has granted Fast Track designation to its product bemnifosbuvir for the treatment of resistant COVID-19.   Bemnifosbuvir is an oral, direct acting...

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April 25, 2023

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Fate Therapeutics: Improving on Cellular Therapies

Fate Therapeutics: Developing Next Generation Cellular Therapies Fate Therapeutics ( FATE ) is a clinical-stage biopharmaceutical company developing first-in-class improved cellular immunotherapies for cancer. Fate Therapeutics uses its proprietary induced pluripotent stem cell ( iPSC ) product platform in clinical development...

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August 25, 2022

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TG Therapeutics: Promising Investigational Monoclonal Antibody Ublituximab for Relapsing Form of M.S.

TG Therapeutics Results Published in NEJM TG Therapeutics ( TGTX ) results from the ULTIMATE I & II Phase 3 trials evaluating the firm’s investigational monoclonal antibody product ublituximab in patients with relapsing forms of multiple sclerosis ( RMS )...

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August 31, 2022

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Vir Biotechnology and GlaxoSmithKline: The European Medicines Agency Started a Review of VIR-7831 for COVID-19

Vir Biotechnology and GlaxoSmithKline in April 2020  In April 2020, Vir Biotechnology and GlaxoSmithKline entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2 (the virus that causes COVID-19). The collaboration uses Vir’s proprietary monoclonal antibody platform...

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April 20, 2021

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Humanigen Inc Product Lenzilumab Combination with CAR T in DLBCL Protects from Severe Cytokine Syndrome

Humanigen Product Lenzilumab Combination with CAR-T At the recommended Phase 2 dose, lenzilumab in combination with CAR-T demonstrated a 100% objective response rate and no severe cytokine release syndrome or severe neurotoxicity Lenzilumab reduced IL-6, CRP, ferritin, MCP-1, IL-8, and...

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April 21, 2021

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Amylyx Pharmaceuticals Announces FDA Approval of RELYVRIO™ for of ALS Leading to a Weird Stock Market Reception

Amylyx Pharmaceuticals in the NEWS Amylyx Pharmaceuticals ( AMLX ) announced that the U.S. FDA has approved RELYVRIO™ (sodium phenylbutyrate and taurursodiol) for the treatment of adults with amyotrophic lateral sclerosis ( ALS ). The product, RELYVRIO, (previously known as...

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September 30, 2022

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Sanofi and AstraZeneca: Nirsevimab Protects Healthy Pre-Term and Term Infants from Respiratory Syncytial Virus

Sanofi and AstraZeneca MELODY Trial Results for Nirsevimab In March 2017, Sanofi ( SNY ) and AstraZeneca ( AZN ) announced an agreement upon which they develop and commercialize nirsevimab. Under the terms of the agreement, Sanofi will lead commercialization...

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April 27, 2021

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Cullinan Oncology to Present First Monotherapy Clinical Data for CLN-619 at ASCO 2023

Inside the Revolution In the Treatments of Untreatable Diseases We are now living a great revolution in the treatment of diseases. We expect to discover novel treatments capable of defeating cancers’ resistance to therapeutics old and new. We are following...

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May 26, 2023

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