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Category: Today’s Highlights

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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Gilead Sciences: FDA Fully Approves Trodelvy for Metastatic TNBC

Gilead Sciences is Granted FDA Approva l for Trodelvy® Gilead Sciences ( GILD ) , a company that has been granted more approvals than many are aware of except for the short analysts and their followers, today announced that the...

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April 8, 2021

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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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The FDA Granted Breakthrough Therapy Designation to vTv Therapeutics for Type 1 Diabetes Product TTP399

vTv Therapeutics Receives Breakthrough Therapy Designation for TTP399 vTv Therapeutics ( VTVT ) - a clinical-stage biopharmaceutical company focused on the development of oral treatments for type 1 diabetes, psoriasis, and other diseases, announced that the U.S. FDA has granted...

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April 13, 2021

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Reata Pharmaceuticals Announces Extension of Review Period for Omaveloxolone NDA for Friedreich’s Ataxia

Reata Pharmaceuticals in the NEWS Reata Pharmaceuticals ( RETA ) on August 8, 2022, after the U.S. financial markets closed, received a communication from the U.S. Food and Drug Administration ( FDA ) informing us that they have extended the...

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August 9, 2022

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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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Inovio DNA Vaccine Candidate INO-4800 has Promising Results. Read Also: Sutro Biopharma Good News

Inovio Pharmaceuticals Promising Results for INO-4800 for COVID-19 Inovio Pharmaceuticals ( INO ) announces promising results of a study focusing on the human immune responses induced by Inovio DNA vaccine candidate, INO-4800, against COVID-19, and variants of concern. The results...

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April 15, 2021

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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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Gilead Sciences Stock Rallies Following Improving Survival of Pre-Treated HR+/HER2- Metastatic Breast Cancer

Gilead Sciences Good News for Breast Cancer Gilead Sciences' ( GILD )  product Trodelvy® has significantly improved the Overall Survival ( OS ) in Pre-Treated HR+/HER2- metastatic breast cancer patients in the TROPiCS-02 study. Today, Gilead Sciences' ( GILD )...

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August 15, 2022

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