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Category: Today’s Highlights

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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Halozyme Announced Janssen Received U.S. FDA Approval of DARZALEX FASPRO®. See Also: IVERIC bio News

Halozyme Therapeutics Announced US FDA Approval for Janssen Biotech's DARZALEX FASPRO® Halozyme Therapeutics ( HALO ) announced that Janssen Biotech, Inc. (Janssen) received U.S. FDA approval of DARZALEX FASPRO® (daratumumab + hyaluronidase-fihj) in combination with pomalidomide and dexamethasone ( Pd )...

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July 13, 2021

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Neurocrine Biosciences Announced Positive Results from Phase 3 CAHtalyst™ Study

Neurocrine Biosciences Announcement Today, Neurocrine Biosciences ( NBIX ) announced positive top-line data from the Phase 3 CAHtalyst™ Pediatric Study evaluating the safety, efficacy and tolerability of the firm’s product crinecerfont treating children and adolescents with classic congenital adrenal hyperplasia...

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October 5, 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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Important Steps Forward Taken by Vir Biotechnology and Separately by Compugen

Vir Biotechnology Vir Biotechnology ( VIR ) announced the dosing of the first patient in the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial to evaluate VIR-2218 together with VIR-3434 for the treatment of patients with chronic...

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July 15, 2021

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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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Why Cytokinetics' Stock Price Soared in a Bad Market Day

Cytokinetics Positive Topline Results of CK-274 Cytokinetics ( CYTK ) announced positive topline results of Phase 2 clinical trial of CK-274 - an investigational cardiac myosin inhibitor in development for the potential treatment of hypertrophic cardiomyopathy ( HCM ). The...

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July 19, 2021

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Akero Therapeutics' October 10, 2023 Press Release

Akero Therapeutics Press Release Akero Therapeutics Reports Encouraging 36-Week Analysis of 96-Week Phase 2b SYMMETRY Study, with a Trend on Fibrosis Improvement and Statistically Significant Results for NASH Resolution, Markers of Liver Injury and Fibrosis, Insulin Sensitization and Lip Akero...

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October 10, 2023

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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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