FDA

X-Therma Announces XT-Thrive® Drug Master File (DMF) Accepted by U.S. Food and Drug Administration (FDA)

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X-Therma Announces XT-Thrive® Drug Master File (DMF) Accepted by U.S. Food and Drug Administration (FDA)

X-Therma Inc., a biotechnology company developing a breakthrough platform for regenerative medicine and organ preservation, announces that...

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vTv Therapeutics Announces FDA Submission for First Phase 3 Study of Cadisegliatin in Patients with Type 1 Diabetes

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vTv Therapeutics Announces FDA Submission for First Phase 3 Study of Cadisegliatin in Patients with Type 1 Diabetes

vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin (TTP399) as an...

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SpringWorks Therapeutics Initiates Rolling Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN

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SpringWorks Therapeutics Initiates Rolling Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN

SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced...

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Danone North America Announces the FDA’s Decision on Their Petition for the First-Ever Qualified Health Claim for Yogurt, Linking This Dairy Aisle Staple to a Reduced Risk of Type 2 Diabetes

3 min read

Danone North America Announces the FDA’s Decision on Their Petition for the First-Ever Qualified Health Claim for Yogurt, Linking This Dairy Aisle Staple to a Reduced Risk of Type 2 Diabetes

 In response to a petition submitted by food and beverage leader Danone North America, the U.S. Food and...

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Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for Novel MICA/B Antibody, CLN-619, for Relapsed/Refractory Multiple Myeloma

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Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for Novel MICA/B Antibody, CLN-619, for Relapsed/Refractory Multiple Myeloma

Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced the U.S. Food...

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PCM Trials Acquires EmVenio Research to Create the Most Patient-Centric Model for Hybrid and Decentralized Clinical Trials

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PCM Trials Acquires EmVenio Research to Create the Most Patient-Centric Model for Hybrid and Decentralized Clinical Trials

Denver-based PCM Trials, the largest independent mobile research nurse visit provider for decentralized clinical trials (DCTs), today announced...

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The New England Journal of Medicine Publishes Positive Phase 3 RESPONSE Data of CymaBay’s Seladelpar in Primary Biliary Cholangitis

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The New England Journal of Medicine Publishes Positive Phase 3 RESPONSE Data of CymaBay’s Seladelpar in Primary Biliary Cholangitis

CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other...

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PharmaTher’s Sairiyo Therapeutics Inc. Advances Clinical Development of Patented Reformulated Cepharanthine for Phase 1 Study in Australia

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PharmaTher’s Sairiyo Therapeutics Inc. Advances Clinical Development of Patented Reformulated Cepharanthine for Phase 1 Study in Australia

PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, announced today...

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United States Food & Drug Administration (FDA) Grants Mesoblast Orphan-Drug Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease

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United States Food & Drug Administration (FDA) Grants Mesoblast Orphan-Drug Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease

Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the...

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Brii Biosciences Announces Agreement to Acquire VBI’s IP Rights in BRII-179 (VBI-2601) and Plans to Initiate Technology Transfer to Expand Clinical and Commercial Supplies

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Brii Biosciences Announces Agreement to Acquire VBI’s IP Rights in BRII-179 (VBI-2601) and Plans to Initiate Technology Transfer to Expand Clinical and Commercial Supplies

Brii Biosciences Limited (“Brii Bio,” “we,” or the “Company”, stock code: 2137.HK), a biotechnology company developing therapies to...

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