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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. ....

United Kingdom , United States , City Of , Julia Wilson , Susana Noonan , Olivia Manser , Sa Noonan Communications , Company Marketing Authorization Application , Exchange Commission , European Medicines Agency , Prescription Drug User Fee Act , Marketing Authorization Application , B Cell Acute Lymphoblastic Leukemia , Christian Itin , Chief Executive Officer , Orphan Drug Designation , Orphan Medical Product Designation , Regenerative Medicine Advanced Therapy , Autolus Therapeutics , Private Securities Litigation Reform Act , Autolu Annual Report ,

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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