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Jan 30, 2023, 10:00 ET Help Therapeutics anuncia la aprobación del IND de la primera terapia de cardiomiocitos derivada de iPSC

Help Therapeutics Co., Ltd. (en adelante, Help Therapeutics) ha revelado que el Centro de Evaluación de Medicamentos de China (CDE) ha aprobado la...

Jan 30, 2023, 10:00 ET Help Therapeutics annonce l'approbation IND du premier traitement cardiomyocytaire universel à base d'iPSC pour l'insuffisance cardiaque terminale en Chine

Help Therapeutics Co., Ltd. (ci-après Help Therapeutics) a révélé que le China Center for Drug Evaluation (CDE) a approuvé l'utilisation d'un nouveau ...

Jan 30, 2023, 10:00 ET Help Therapeutics gibt IND-Zulassung der ersten universellen, aus iPS-Zellen (induzierte pluripotente Stammzellen) gewonnenen Kardiomyozyten-Therapie für Herzinsuffizienz im Endstadium in China bekannt

Help Therapeutics Co., Ltd. (im Folgenden „Help Therapeutics") hat bekannt gegeben, dass das China Center for Drug Evaluation (CDE) den Antrag auf...

Jan 30, 2023, 10:00 ET Help Therapeutics Announces IND Approval of First Universal iPSC-derived Cardiomyocyte Therapy for End-stage Heart Failure in China

Help Therapeutics Co., Ltd. (hereinafter Help Therapeutics) has revealed that the China Center for Drug Evaluation (CDE) has approved the...

Jan 30, 2023, 10:00 ET Help Therapeutics Announces IND Approval of First Universal iPSC-derived Cardiomyocyte Therapy for End-stage Heart Failure in China

Help Therapeutics Co., Ltd. (hereinafter Help Therapeutics) has revealed that the China Center for Drug Evaluation (CDE) has approved the...

Jan 30, 2023, 08:37 ET United Recovery Project, Services for Addiction Recovery

United Recovery Project provides a comprehensive range of services, including detoxification, inpatient treatment, outpatient programs, and...

Jan 27, 2023, 08:38 ET Infinity Neuro Receives CE Mark Approval for Their First Device to Treat Stroke

LAKE FOREST, Calif., Jan. 27, 2023 Infinity Neuro announced today that its Inspira™ aspiration catheters received CE Mark approval and are now...

Jan 23, 2023, 08:00 ET U.S. Patent Office Grants Notice of Allowance to IceCure for Novel Cryogenic Pump for Next-Generation Cryoablation Systems

IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® ...

Jan 23, 2023, 07:00 ET CytoSorbents Announces Health Canada Regulatory Approval For Pivotal STAR-T Trial

CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery...

Jan 19, 2023, 08:00 ET NICE Recommends Reimbursement for Translarna™

PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the National Institute for Health and Care Excellence (NICE) has issued a Final Evaluation ...

Jan 18, 2023, 08:33 ET Innovent Announces Inclusion in the China National Reimbursement Drug List (NRDL) of TYVYT in Two New Indications, Olverembatinib for the First Listing, BYVASDA, HALPRYZA and SULINNO in Multiple New Indications

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high...

Jan 18, 2023, 08:00 ET Novavax Nuvaxovid COVID-19 Vaccine Approved in South Korea as an Adult Booster

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious...

Jan 17, 2023, 08:00 ET AffaMed Therapeutics to commercialize Galcanezumab for Migraine Prevention in Mainland China

AffaMed Therapeutics ("AffaMed"), a global clinical stage biopharmaceutical company dedicated to address critical unmet medical needs in...

Jan 17, 2023, 05:29 ET Henlius' Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Approved for the Treatment of ES-SCLC

Shanghai Henlius Biotech, Inc. (2696. HK) announced that its first self-developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (generic ...

Jan 10, 2023, 04:03 ET Dizal Announces China CDE Acceptance of New Drug Application for Sunvozertinib for Platinum-Pretreated NSCLC Patients with EGFR Exon20ins Mutations

Dizal (SHEX: 688192) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has...

Jan 09, 2023, 08:00 ET SK bioscience's Zoster Vaccine Receives Biologics License Application Approval in Malaysia

SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure across the globe,...

Jan 03, 2023, 16:05 ET European Medicines Agency Validates Application for Extension of Indication for VOXZOGO® (vosoritide) for injection to Treat Children with Achondroplasia Under the Age of 2

BioMarin Pharmaceutical Inc. (NASDAQ: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, announced...

Jan 03, 2023, 07:00 ET ProfoundBio Announces Initiation of First-in-Human Trial for PRO1184, a Folate Receptor Alpha-Directed ADC with a Topoisomerase 1 Inhibitor Payload, and Receives FDA "Study May Proceed" Letter for PRO1160, a CD70-Directed ADC

ProfoundBio, a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics, announced that 1) dosing has...

Dec 29, 2022, 04:17 ET Cabozantinibe é aprovado para tratamento de câncer diferenciado de tireoide

A Agência Nacional de Vigilância Sanitária (Anvisa) aprovou em 26/12/2022 o inibidor multiquinases Cabometyx® (levomalato de cabozantinibe) para o...

Dec 22, 2022, 07:41 ET REDUVO™ Marketing Approval on the Right Path

Second Clarifax received from Health Canada. MONTREAL, Dec. 22, 2022 /PRNewswire/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP)...

Dec 22, 2022, 03:38 ET U.S. FDA Approves Clinical Trial Application for IASO Bio's BCMA CAR-T CT103A for Relapsed/Refractory Multiple Myeloma

IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell...

Dec 21, 2022, 09:00 ET Abbott's FreeStyle Libre® 3 Integrated with Automated Insulin Delivery System mylife™ Loop in Germany

Abbott (NYSE: ABT) today announced that its FreeStyle Libre® 3 sensor is now compatible with the mylife™ Loop solution from partners, Ypsomed and...

Dec 21, 2022, 03:48 ET Zynlonta® (loncastuximab tesirine) approved in the EU for the treatment of relapsed or refractory diffuse large B-cell lymphoma

Sobi® and ADC Therapeutics SA today announced that the European Commission (EC) has granted conditional marketing authorisation for the use of...

Dec 19, 2022, 08:00 ET SeekIn Receives CE-IVD Mark Approval for PanCanSeek® Cancer Mutation Detection Kit

SeekIn Inc, a leader in blood-based cancer early detection and monitoring technology, today announced CE (Conformité Européenne) Mark approval for...

Dec 19, 2022, 07:00 ET Ebvallo® (Tabelecleucel) von Atara Biotherapeutics erhält die Zulassung der Europäischen Kommission als erste Therapie für Erwachsene und Kinder mit EBV+ PTLD

Atara Biotherapeutics, Inc. (Nasdaq: ATRA), und Pierre Fabre gaben heute bekannt, dass die Europäische Kommission (EC) die Zulassung für Ebvallo ®...