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Category: Today’s Highlights

Vertex Receives CHMP Positive Opinion for ORKAMBI in Children with Cystic Fibrosis Aged 1 - >2 Years

Vertex Pharmaceuticals ORKAMBI Receives Positive CHMP Opinion Today, April 27, Vertex Pharmaceuticals  ( VRTX ) announced that the European Medicines Agency’s ( EMA ) Committee for Medicinal Products for Human Use ( CHMP ) embraced a positive opinion for the...

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April 27, 2023

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IVERIC Bio: Undeniable Promising News Today

IVERIC Bio ~ September 6, 2022 IVERIC bio ( ISEE ) announced positive results from GATHER2 second Phase 3 clinical trial of Zimura® (avacincaptad pegol) - a novel investigational complement C5 inhibitor for the treatment of geographic atrophy ( GA...

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September 6, 2022

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ImmunoGen's Obvious Recent Progress

 ImmunoGen Reports Recent Progress and First Quarter 2023 Financial Results  On April 28, 2023, ImmunoGen ( IMGN ) reviewed recent progress in the business and reported financial results for the quarter ended March 31, 2023.  Immunogen's drug ELAHERE® (mirvetuximab soravtansine-gyn) is...

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April 28, 2023

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Amylyx Pharmaceuticals Announces FDA Advisory Committee Supports Approval of AMX0035 for ALS

Amylyx Pharmaceuticals in the News Amylyx Pharmaceuticals ( AMLX ) : The U.S. FDA Peripheral and Central Nervous System Drugs Advisory Committee has voted (7 yes votes and 2 no votes) that the available evidence of effectiveness is sufficient to support approval of AMX0035...

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September 8, 2022

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Akero Therapeutics: Efruxifermin Met Primary Endpoint for Both Dose Groups in NASH Patients

Akero Therapeutics Akero Therapeutics ( AKRO ) - a clinical-stage company, today released topline data from HARMONY, a 24-week Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin ( EFX ) in patients with pre-cirrhotic...

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September 13, 2022

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Cassava Sciences Guidance for Simufilam. See Also: Its First Quarter 2021 Financial Results

Cassava Sciences Guidance and Financial Results Cassava Sciences ( SAVA ) announced financial results for the first quarter ended March 31, 2021 as well as its guidance regarding the release of new clinical data with simufilam, the Company’s lead drug...

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April 21, 2021

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CHMP Adopts Positive Opinion for Full Marketing Authorization of Gilead’s Hepcludex® Treatment of HDV 

Gilead Sciences CHMP Adopted Positive Opinion for Hepcludex® Today, May 4, 2023, Gilead Sciences ( GILD ) acknowledged that the Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted...

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May 4, 2023

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Intellia Therapeutics: Excellent News from NTLA-2001 Phase 1 Clinical Trial

Intellia Therapeutics  Intellia Therapeutics.( NTLA ) and  Regeneron Pharmaceuticals ( REGN ) today announced positive interim results from an ongoing Phase 1 clinical trial of NTLA-2001, an investigational, in vivo CRISPR/Cas9 genome editing therapy in development as a single-dose treatment for transthyretin (...

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September 16, 2022

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Why CureVac Stock Traded Up in a Bad Day Market

CureVac B.V. CureVac ( CVAC ) is a global biopharmaceutical company in the field of messenger RNA ( mRNA ) technology with more than 20 years of expertise in developing, optimizing and manufacturing this versatile biological molecule for medical purposes....

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May 8, 2023

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Bristol-Myers Squibb: CHMP of the EMA Recommended Additional Approval of Onureg® as Maintenance Therapy for AML

European Authorities Recommended Additional Approval of Bristol-Myers Squibb Product Onureg® for AML Bristol-Myers Squibb ( BMY ) : The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) recommended approval of...

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April 23, 2021

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