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Syncona : Autolus Therapeutics announces acceptance of Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) -April 02, 2024 at 09:14 am EDT

Submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in r/r B-ALL


The US marketing application is under review with a Prescription Drug User Fee Act ...

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Autolus Therapeutics announces acceptance of Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for obecabtagene autoleucel (obe-cel) for Patients with Relapsed/refractory (r/r) Adult B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in r/r B-ALLThe US marketing application is under review with a Prescription Drug User Fee Act target action date of...

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Krystal Biotech Announces EMA Validation of Marketing Authorization Application for VYJUVEK for the Treatment of Dystrophic Epidermolysis Bullosa

Krystal Biotech Announces EMA Validation of Marketing Authorization Application for VYJUVEK for the Treatment of Dystrophic Epidermolysis Bullosa
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Reata Pharmaceuticals Announces Approval of Prior Approval Supplement for SKYCLARYS (Omaveloxolone) and Commercial Availability of SKYCLARYS for Patients with Friedreich's Ataxia Seite 1

28.06.2023 - Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” “our,” “us,” or “we”), a global, biopharmaceutical company focused on developing and commercializing novel therapies for patients with severe diseases, announced that the United ... Seite 1

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Reata Pharmaceuticals Announces Approval of Prior Approval Supplement for SKYCLARYS® (Omaveloxolone) and Commercial Availability of SKYCLARYS for Patients with Friedreich's Ataxia | Region

PLANO, Texas--(BUSINESS WIRE)--Jun 27, 2023--

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Reata Pharmaceuticals Announces Approval of Prior Approval Supplement for SKYCLARYS® (Omaveloxolone) and Commercial Availability of SKYCLARYS for Patients with Friedreich's Ataxia

Reata Pharmaceuticals Announces Approval of Prior Approval Supplement for SKYCLARYS® (Omaveloxolone) and Commercial Availability of SKYCLARYS for Patients with Friedreich's Ataxia
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Stock Market | FinancialContent Business Page

Stock Market | FinancialContent Business Page
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Reata Pharmaceuticals, Inc. Announces First Quarter 2023 Financial Results and Provides an Update on Operational Progress and Clinical Development Programs

SKYCLARYS® Approved by FDA in the U.S.


Approximately 500 Patient Start Forms Received for SKYCLARYS


Marketing Authorization Application for Omaveloxolone in Europe Under Review


Announced... | May 10, 2023

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SIFI Reports Detailed Positive Results and New Data from the Completed Phase 3 Trial of AKANTIOR® in Patients with Acanthamoeba Keratitis presented at the American Academy of Ophthalmology Annual Meeting in Chicago

SIFI Reports Detailed Positive Results and New Data from the Completed Phase 3 Trial of AKANTIOR® in Patients with Acanthamoeba Keratitis presented at the American Academy of Ophthalmology Annual Meeting in Chicago
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Helsinn Healthcare S.A.: Helsinn Group Announces European Medicines Agency's (EMA) Acceptance for review of the Marketing Authorization Application (MAA) for Infigratinib for Patients with Cholangiocarcinoma with Fibroblast Growth Factor Receptor 2 Fusion

Helsinn Group Announces European Medicines Agency's (EMA) Acceptance for review of the Marketing Authorization Application (MAA) for Infigratinib for Patients with Cholangiocarcinoma with

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