Search Results for medicines

Merck

Merck and Mayo Clinic Partner to Advance AI-Driven Drug Discovery and Precision Medicine

Merck and Mayo Clinic Announce New Research and Development Collaboration to Support AI-Enabled Drug Discovery and Precision Medicine Merck  known as MSD outside of the U.S. and Canada, and Mayo Clinic, the world’s top-ranked hospital system, today announced a research and…

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ENHERTU®

ENHERTU® Variation Application Accepted in EU for Post-Neoadjuvant Use in Early HER2-Positive Breast Cancer

ENHERTU® Type II Variation Application Validated in the EU as Post-Neoadjuvant Treatment for Patients with HER2 Positive Early Breast Cancer The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU® (trastuzumab deruxtecan) as a monotherapy for…

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Affinia

Affinia Therapeutics Receives EMA Orphan Designation for Gene Therapy AFTX-201 in BAG3 Cardiomyopathy

Affinia Therapeutics Receives European Medicines Agency Orphan Drug Designation for AFTX-201 in BAG3-Associated Dilated Cardiomyopathy (DCM) Affinia Therapeutics an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies initially for devastating cardiovascular diseases,…

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Korsana Biosciences

Korsana Biosciences Launches with $175 Million to Develop Innovative Neurodegenerative Treatments

Korsana Biosciences Emerges from Stealth with $175 Millon in Funding to Advance Potential Best-in-Class Therapeutics for Neurodegenerative Diseases Korsana Biosciences, Inc. a biotechnology company discovering and developing novel therapies to reduce the burden of neurodegenerative diseases, today announced its emergence…

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Therapeutics

New Study Highlights Flashpoint Therapeutics’ Breakthrough HPV Cancer Vaccine

Flashpoint Therapeutics Announces Major Publication on Novel HPV Cancer Vaccine Flashpoint Therapeutics, a biotechnology company pioneering a new class of structural nanomedicines, today announced a major, peer-reviewed publication demonstrating the power of its Spherical Nucleic Acid (SNA) platform in immuno-oncology.…

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Tirabrutinib

Deciphera’s Tirabrutinib NDA Accepted by FDA for Relapsed or Refractory PCNSL

Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance for Filing of New Drug Application for Tirabrutinib in Patients with Relapsed or Refractory PCNSL Deciphera Pharmaceuticals, a member of Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi…

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FDA

FDA Accepts Bristol Myers Squibb’s NDA for Iberdomide in Relapsed or Refractory Multiple Myeloma

U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s New Drug Application for Iberdomide in Patients with Relapsed or Refractory Multiple Myeloma Bristol Myers Squibb today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug…

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ImmunityBio

ImmunityBio Advances Regulatory Collaboration at USA-Saudi Biotech Alliance Event in Saudi Arabia

ImmunityBio Reports Productive Regulatory Engagement with Saudi Food and Drug Authority at USA-Saudi Biotech Alliance Meeting Hosted by the Ministry of Investment of Saudi Arabia ImmunityBio, Inc. a commercial stage immunotherapy company developing next generation therapies that drive immunological memory…

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ECCO Data

ECCO Data Highlight Remsima™ SC’s Ability to Restore and Sustain Disease Control After Treatment Break

New ECCO data show subcutaneous (SC) infliximab (Remsima™  SC) effectively recaptures and maintains disease control after drug holiday Celltrion, Inc. today announced new data from a post-hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC), showing that subcutaneous (SC) infliximab…

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Genentech

Genentech Highlights Breakthrough Phase III Results for Gazyva in Autoimmune Kidney Disease

Genentech Announces Positive Phase III Results for Gazyva in Primary Membranous Nephropathy, Marking a Significant Milestone in This Autoimmune Disease Genentech, a member of the Roche Group announced today that the Phase III MAJESTY study in adults with primary membranous…

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