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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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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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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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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.
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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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Hera Biotech Announces Positive Interim Results From Endometriosis Diagnostic Study
4/23/2024
Hera Biotech is pleased to report the interim results for its proof-of-concept multi-center clinical trial of the MetriDx™ endometriosis diagnostic test.
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Alto Neuroscience Announces Positive Phase 1 Results for ALTO-101, a Novel PDE4 Inhibitor in Development for Schizophrenia
4/23/2024
Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today announced positive results from its healthy volunteer Phase 1 study of ALTO-101, a novel PDE4 inhibitor in development for cognitive impairment associated with schizophrenia (CIAS).
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Enzolytics Inc. Announces Dismissal of The Dimitar Savov Lawsuit in Nevada
4/23/2024
Enzolytics, Inc. today disclosed that on April 9, 2024, the US District Court of Nevada dismissed the lawsuit, 22-cv-00401-GMN-DJA brought by Dimitar Savov against IMMB bringing to an end the claims alleged in this suit. Originally filed on March 3, 2022 against the corporation that ENZC had its assets, including ITV-1, IMMB and ENZC have successfully defended their position against the plaintiff through 2 years of litigation. Enzolytics will continue to aggressively defend any litigation..
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Vertex and TreeFrog Therapeutics Announce Licensing Agreement and Collaboration to Optimize Production of Vertex's Cell Therapies for Type 1 Diabetes
4/23/2024
Vertex Pharmaceuticals Incorporated and TreeFrog Therapeutics announced that Vertex has obtained an exclusive license to TreeFrog's proprietary cell manufacturing technology, C-StemTM, to optimize production of Vertex's cell therapies for type 1 diabetes.
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Health Canada authorizes Tecentriq SC (atezolizumab, solution for subcutaneous injection), the first cancer immunotherapy subcutaneous injection, for multiple cancer types
4/23/2024
Health Canada authorizes Tecentriq SC (atezolizumab, solution for subcutaneous injection), the first cancer immunotherapy subcutaneous injection, for multiple cancer types.
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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.