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Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
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Follow along as BioSpace keeps you up to date on the latest pharma and biotech M&As, from announcements to closings.
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Neurocrine Biosciences Reports Positive Phase 2 Data for NBI-1065845 in Adults with Major Depressive Disorder
4/23/2024
Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced positive topline data for its Phase 2 SAVITRI™ study. This randomized, double-blind, placebo-controlled dose-finding study assessed the efficacy and safety of NBI-1065845 in adult subjects with major depressive disorder (MDD).
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SpecialtyVETPATH Taps Proscia For A Full Transformation Of Its Pathology Operations
4/23/2024
SpecialtyVETPATH, a private, pathologist-owned, and pathologist-directed veterinary pathology laboratory, has selected Proscia®, a leading provider of digital and computational pathology solutions
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Lipid Nanoparticles (LNPs) CDMO Market to Reach USD 518.2 Million with a CAGR of 14.10% from 2024-2031
4/23/2024
Global Lipid Nanoparticles (LNPs) CDMO Market in terms of revenue was predicted to be worth $182.0 Mn in 2023 and is poised to reach 518.2 Mn by 2031, increasing at a CAGR of 14.10% from 2024 to 2031.
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Predictive Biomarkers Market in North America is Expected to Grow with the Highest CAGR – Here’s Why
4/23/2024
Global Predictive Biomarkers Market in terms of revenue is poised to grow at a CAGR of 14.27% from 2024 to 2031.
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hC Bioscience Announces Lead Program in Hemophilia and Reports Positive Preclinical Data on Novel Protein Editing Approach Using Anticodon Engineered tRNA
4/23/2024
hC Bioscience today announced preclinical data supporting its lead program in severe hemophilia A at the World Federation of Hemophilia 2024 World Congress in Madrid, Spain.
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Pillar Biosciences oncoReveal™ CDx pan-cancer solid tumor IVD now FDA approved for general tumor profiling on the Illumina MiSeq™ Dx System
4/23/2024
Pillar Biosciences, Inc., the leader in Decision Medicine™ today announced that the U.S. Food and Drug Administration (FDA) has approved the company's Premarket Approval (PMA) supplement application for its oncoReveal™ CDx pan-cancer solid tumor in vitro diagnostic (IVD).
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OncoC4 Announces FDA Clearance of IND Application for Novel SIGLEC 10 Immune Checkpoint Inhibitor ONC-841 for Solid Tumors
4/23/2024
OncoC4, Inc today announced that the United States Food and Drug Administration (“FDA”) has cleared the investigational new drug (“IND”) application for ONC-841, a potential first-in-class SIGLEC 10 blocking antibody for the treatment of solid tumors.
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Exo® Launches FDA-Cleared AI on Exo Iris™ to Address Heart Failure
4/23/2024
Exo ® Launches FDA-Cleared AI on Exo Iris™ to Address Heart Failure.
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SAIL Fusion Announces FDA Clearance of its BowTie™ Sacroiliac Fusion System
4/23/2024
SAIL Fusion, a medical device company focused on advancing the surgical treatment of sacroiliac joint dysfunction through solutions built upon proven AO principles, today announced that it has received FDA clearance for its novel BowTie Sacroiliac Fusion System.
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Press Release: Rilzabrutinib LUNA 3 phase 3 study met primary endpoint in immune thrombocytopenia
4/23/2024
Positive results from the LUNA 3 phase 3 study demonstrated that rilzabrutinib 400 mg twice daily orally achieved the primary endpoint of durable platelet response in adult patients with persistent or chronic immune thrombocytopenia.
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Palisade Bio Enters into Strategic Collaboration with Strand Life Sciences to Advance Precision Medicine Approach
4/23/2024
Palisade Bio, Inc. today announced it has entered into a transformative strategic collaboration with Strand Life Sciences, a leading bioinformatics specialist, aimed at advancing precision medicine for ulcerative colitis (UC) therapy.
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INmune Bio Inc. Announces 24-Month Stability Validation of XPro™ for Phase III Readiness and Commercial Supply Chain Modeling & Development of Novel Immunogenicity Assay
4/23/2024
INmune Bio, Inc. is delighted to announce the successful completion of the extended stability validation for XPro TM continuous storage in solution at 2-8C.
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UNITY Biotechnology Announces Extension of Phase 2b ASPIRE Clinical Study Evaluating UBX1325 in DME
4/23/2024
UNITY Biotechnology, Inc. today announced that the ongoing Phase 2b ASPIRE study of UBX1325 has been extended from 24 to 36 weeks to assess potentially greater durability compared to aflibercept.
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Flare Therapeutics Appoints Douglas Manion, M.D., FRCP (C) as Chief Executive Officer
4/23/2024
Flare Therapeutics Inc. today announced the appointment of Douglas Manion, M.D., FRCP (C), as Chief Executive Officer, effective immediately.
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Edgewise Receives European Medicines Agency (EMA) Orphan Drug Designations for Sevasemten (EDG-5506) for the Treatment of Becker and Duchenne Muscular Dystrophies
4/23/2024
Edgewise Therapeutics, Inc. today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designations for sevasemten for the treatment of Becker muscular dystrophy (Becker) and for the treatment of Duchenne muscular dystrophy (Duchenne).
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Seamless Therapeutics Announces New CEO and Board Chairman to Support US Expansion of Programmable Recombinase Gene Editing Technology Platform
4/23/2024
Seamless Therapeutics today announced the appointments of Albert Seymour, Ph.D., as its new President and Chief Executive Officer and Adam Rosenberg as Independent Chairman of the company’s Board of Directors.
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SOPHiA GENETICS Announces Syndicate Bio as First Liquid Biopsy Customer in Africa
4/23/2024
SOPHiA GENETICS, a cloud-native software company in the healthcare space and a leader in data-driven medicine, announced that Nigeria-based Syndicate Bio has signed on to implement MSK-ACCESS® powered with SOPHiA DDM™.