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Data from the Phase III LUNA 3 study on Tuesday showed that Sanofi’s BTK inhibitor rilzabrutinib significantly improved durable platelet response in patients with chronic immune thrombocytopenia.
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CEO Hervé Hoppenot said Tuesday on an investor call that Escient Pharmaceuticals’ two lead assets “address large populations with a clear medical need” with a potential multibillion-dollar market opportunity.
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Bouncing back from a previous rejection, ImmunityBio on Monday secured the FDA’s green light for its IL-15 superagonist Anktiva for non-muscle invasive bladder cancer.
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The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.
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The U.S. Supreme Court on Monday indicated that it will not hear Vanda Pharmaceuticals’ petition in its patent case against Teva Pharmaceuticals regarding the former’s sleep-wake disorder drug Hetlioz.
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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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Curium Enrolls First Prostate Cancer Patients in its Phase 3 SOLAR Trials
4/23/2024
Curium, a world leader in nuclear medicine, announced today that it has successfully enrolled and scanned patients in its SOLAR clinical trials.
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Vanda Pharmaceuticals Reacts to U.S. Supreme Court's Denial of its Petition in HETLIOZ® ANDA Litigation
4/23/2024
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the Supreme Court denied Vanda's petition for a writ of certiorari in its HETLIOZ ® Abbreviated New Drug Application litigation against Teva Pharmaceuticals USA , Inc.
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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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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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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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Neuronoff Announces Safety and Functionality Success in First-in-Human Trial of Injectrode for Minimally Invasive Chronic Pain Relief (LIFE study)
4/23/2024
Neuronoff, Inc. announced a significant milestone in its mission to transform chronic pain management.
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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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Response Pharmaceuticals’ Drug Candidate for the Treatment of Antipsychotic-Induced Weight Gain (AIWG) Achieves Primary Endpoint in Phase 1b Clinical Trial
4/23/2024
Response Pharmaceuticals, Inc today announced positive topline results from its Phase 1b clinical trial evaluating the safety and efficacy of RDX-002.
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ImmunityBio Announces FDA Approval of ANKTIVA®, First-in-Class IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
4/23/2024
ImmunityBio, Inc., an immunotherapy company, announced that the U.S. Food and Drug Administration has approved ANKTIVA plus Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
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Artelo Biosciences Announces Publication of Peer-Reviewed Article Highlighting FABP7 as a Promising Novel Target in Cancer Therapy
4/23/2024
Artelo Biosciences, Inc. today announced the publication of an article, “The emerging role of fatty acid binding protein 7 (FABP7) in cancers,” in Drug Discovery Today, a peer-reviewed journal.
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Brise Pharmaceuticals Raises nearly $20M in Series Pre-A and Pre-A+ Financing
4/23/2024
Brise Pharmaceuticals Co., LTD., a pioneering company specializing in innovative treatments for acute and chronic pain, has recently completed Pre-A and Pre-A+ financing with a total of approximately $20 million.