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Category: News & Comments

Takeda Pharmaceutical Product LIVTENCITY Granted Approval by the FDA

Takeda Pharmaceutical Granted FDA Approval for LIVTENCITY for Post-Transplant Cytomegalovirus On November 23, 2021 Takeda Pharmaceutical Co Ltd ( TAK ) announced that the U.S. FDA has approved LIVTENCITY™ (maribavir) for adults and pediatric patients (12 years of age or...

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November 25, 2021

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Avista Therapeutics Partners with Roche to Develop Advanced AAV Gene Therapy Vectors for Ocular Diseases

Avista Therapeutics Avista Therapeutics’ mission is to develop innovative gene therapies for retinal diseases, including rare ophthalmic conditions that have a profound impact on patients' quality of life. Avista leverages its computationally guided single-cell adeno-associated virus engineering ( scAAVengr )...

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July 20, 2022

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Regenxbio Announced the First Patient has been Dosed in the Phase I/II trial of RGX-111 for MPS I

Regenxbio Dosed First Patient with RGX-111 for MPS I Regenxbio ( RGNX ) has dosed the first patient with RGX-111 in the Phase I/II trial for the treatment of Mucopolysaccharidosis Type I ( MPS I ). About Regenxbio Product RGX-111...

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December 1, 2020

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The FDA Cleared the IND for Erasca Inc Product ERAS-801 for Recurrent Glioblastoma

Erasca Inc Product ERAS-801 IND Cleared by FDA Erasca Inc ( ERAS )  announced that the United States Food and Drug Administration ( FDA ) has cleared an investigational new drug ( IND ) application for ERAS-801, an orally available small...

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December 17, 2021

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Gilead Sciences has Good News for Relapsed or Refractory Mantle Cell Lymphoma and More

Gilead Sciences Company, Kite Pharma, News Kite Pharma, a Gilead Company ( GILD ) , announced that the European Commission has granted conditional marketing authorization for Tecartus™ (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). Tecartus is a chimeric antigen receptor ( CAR...

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December 16, 2020

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Hutchmed: Treating Advanced Metastatic Colorectal Cancer and Other Treatment Resistant Cancers

Hutchmed: Treating Advanced Refractory Metastatic Colorectal Cancer On August 8, 2022,  Hutchmed ( HCM ) announced that pivotal global Phase 3 FRESCO-2 trial evaluating the investigational use of fruquintinib met its primary endpoint of overall survival ( OS ) in...

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August 10, 2022

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Regenxbio: Advancing its Gene Therapy Pipeline and its Rare Neurodegenerative Disease Platform with Non-Dilutive Capital

Regenxbio Regenxbio ( RGNX ) announced that it is selling a portion of its royalty rights from the net sales of Zolgensma® by Novartis to entities managed by Healthcare Royalty Management, LLC ( HCR ) for $200 million. This transaction...

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December 23, 2020

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The FDA Authorized Emergency Use of Pfizer Paxlovid Pills Against COVID-19

Pfizer Received Emergency Use Authorization from the FDA for Paxlovid Pills for COVID-19 Good news for Pfizer ( PFE ), the U.S. FDA announced it has authorized the emergency use of PAXLOVID™ for the treatment of mild-to-moderate COVID-19 in adults...

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December 25, 2021

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Intellia Therapeutics to Present Data from Clinical Trial of NTLA-2002 Aimed at Treating Hereditary Angioedema

Intellia Therapeutics to Present Interim Clinical Data from NTLA-2002 Trial for Hereditary Angioedema An abstract featuring interim clinical data from the Phase 1/2 study of Intellia Therapeutics’ ( NTLA ) product NTLA-2002 has been selected for an oral presentation at the...

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August 30, 2022

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Exelixis: The FDA Approved Cabometyx in Combination with Opdivo as a First Line Treatment of RCC

Exelixis: FDA Approval for Cabometyx in Combination with Opdivo  Exelixis ( EXEL ) announced that the United States FDA has approved CABOMETYX (cabozantinib) in combination with OPDIVO® (nivolumab) as a first-line treatment for patients with advanced renal cell carcinoma ( RCC...

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January 23, 2021

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