Category: Today’s Highlights

Intellia Therapeutics Announces FDA Clearance of IND Application for NTLA-2002 Therapy for the Treatment of Hereditary Angioedema

Intellia Therapeutics  Intellia Therapeutics ( NTLA ) announced that the U.S. FDA has cleared the company’s Investigational New Drug ( IND ) application for NTLA-2002.  About NTLA-2002 Based on Nobel Prize-winning CRISPR/Cas9 technology, NTLA-2002 is the first single-dose investigational treatment. NTLA-2002...

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March 2, 2023

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BrainStorm Cell Therapeutics: Another Clinical-Stage Small Firm's Product for the Devastating Disease ALS

BrainStorm Cell Therapeutics Inc BrainStorm Cell Therapeutics Inc ( BCLI ) develops innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous...

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March 27, 2023

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The U.S. FDA Accepted Checkpoint Therapeutics Biotech BLA for Cosibelimab

Checkpoint Therapeutics Checkpoint Therapeutics ( CKPT ) is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab,...

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March 31, 2023

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The EU CHMP Agency Recommended Approval of TG Therapeutics Firm's BRIUMVI™ for Relapsing Forms of MS in Adults

TG Therapeutics TG Therapeutics, Inc. ( TGTX ) announced today that the Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has issued a positive opinion recommending the approval of BRIUMVITM...

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March 31, 2023

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Vertex and CRISPR Complete Submission of BLAs to the US FDA for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

Vertex Pharmaceuticals and CRISPR Therapeutics Completion of BLAs Vertex Pharmaceuticals ( VRTX ) and CRISPR Therapeutics ( CRSP ) announced the completion of the rolling Biologics License Applications ( BLAs ) to the FDA for the investigational treatment exagamglogene autotemcel...

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April 3, 2023

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Regenxbio Receives FDA Fast Track Designation for RGX-202 for the Treatment of Duchenne Muscular Dystrophy  

Regenxbio in the NEWS Today, the U.S. FDA granted Fast Track designation for Regenxbio ( RGNX ) Gene therapy RGX-202 a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne). Therapies granted Fast Track designation are given the...

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April 11, 2023

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Why the FDA Accepted to Review Merck's KEYTRUDA (sBLA) for The Treatment of HER2 Negative Gastric Adenocarcinoma

Merck in the NEWS Merck ( MRK ) announced that the U.S. FDA has accepted for review a new supplemental Biologics License Application ( sBLA ) seeking approval for KEYTRUDA (pembrolizumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the...

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April 14, 2023

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Important News from Novartis MS Product Kesimpta®

From Novartis on April 20, 2023 The ALITHIOS open-label extension study demonstrated that continuous treatment with Kesimpta® (ofatumumab) for up to five years in relapsing multiple sclerosis ( RMS ) was associated with reduced risk of disability progression versus those who...

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April 20, 2023

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CymaBay Therapeutics: Results From Phase 3 Study of Seladelpar in Patients with PBC Published in Hepatology

Important News from CymaBay Therapeutics Primary Biliary Cholangitis Today, April 21, 2023, CymaBay Therapeutics ( CBAY )  announced that results from the ENHANCE phase 3 global study evaluating seladelpar for Primary Biliary Cholangitis ( PBC ) have been published in...

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April 21, 2023

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Apellis Pharmaceuticals: Validation of 4 Marketing Applications for Pegcetacoplan for Geographic Atrophy

Apellis Pharmaceuticals Validation for Pegcetacoplan Apellis Pharmaceuticals ( APLS ) announced the receival of validation of its marketing applications by regulatory authorities in Canada, Australia, the United Kingdom, and Switzerland for intravitreal pegcetacoplan regarding the treatment of geographic atrophy ( GA...

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April 21, 2023

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