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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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BIMZELX (bimekizumab) Now Approved for Adults with Active Psoriatic Arthritis and for Adults with Axial Spondyloarthritis
3/14/2024
Today, UCB Canada Inc. is pleased to announce that BIMZELX® (bimekizumab injection) has received authorization from Health Canada for two new indications.
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UC Berkeley Launches New Molecular Therapeutics Initiative to Accelerate Drug Discovery
3/14/2024
The University of California, Berkeley Molecular Therapeutics (MTx) division of the Molecular & Cell Biology department today announced the launch of a new initiative to accelerate drug discovery at the interface of academia and biotech.
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First Presentation of Year 4 BIMZELX® (bimekizumab-bkzx) Data Showed Long-Term Maintenance of Complete Skin Clearance in Moderate-to-Severe Plaque Psoriasis
3/9/2024
UCB, a global biopharmaceutical company, announced that the first presentations of BIMZELX® four-year efficacy and safety data in the treatment of adults with moderate-to-severe plaque psoriasis are being shared this week at the 2024 American Academy of Dermatology Annual Meeting in San Diego, California, March 8–12.
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BIMZELX® 48-Week Phase 3 Analyses in Moderate-to-Severe Hidradenitis Suppurativa Showed Sustained Improvements in Skin Pain and Draining Tunnel Count
3/8/2024
UCB, a global biopharmaceutical company, today announced 48-week post-hoc analyses of pooled Phase 3 data from the BE HEARD I and BE HEARD II studies examining the impact of BIMZELX on skin pain and draining tunnels in adults with moderate-to-severe hidradenitis suppurativa (HS).
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Asha Therapeutics to Present at AD/PD™ 2024 International Conference and Announces Clinical Development Plan for Lead Programs Anticipated to Enter Clinical Trials this Year and Welcomes Two New SAB Members
3/8/2024
Asha Therapeutics (Asha), ( www.ashatherapeutics.com ), a life sciences company, is leveraging its revolutionary PRISM™ drug design technology to create novel medicines to restore normal biology and provide functional cures for many difficult to treat diseases with a high unmet medical need.
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Praxis Precision Medicines Provides Corporate Update and Reports Fourth Quarter and Full-Year 2023 Financial Results
3/5/2024
Praxis Precision Medicines, Inc. provided a corporate update and reported financial results for the fourth quarter and full-year 2023.
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Tonix Pharmaceuticals Announces Translation of Preclinical Pharmacokinetic Parameters of TNX-1500 (Fc-modified humanized anti-CD40L mAb) Supports Monthly i.v. Dosing in Humans
3/5/2024
Tonix Pharmaceuticals Holding Corp. today announced the results of modeling key human pharmacokinetic (PK) properties for TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* from animal studies.
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UCB on Growth Path for a Decade Plus
2/28/2024
Our 2023 performance showcases our unwavering commitment to ensuring people with severe diseases can live the life they like, as free as possible from challenges of disease, reaching more than 3.2 million patients globally with severe immunological and neurological conditions.
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Tonix Pharmaceuticals Completes Clinical Stage of Phase 1 Trial for TNX-1500 (Fc-modified humanized anti-CD40L mAb) in Healthy Volunteers
2/28/2024
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the completion of the clinical stage of its Phase 1, single ascending dose escalation trial of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* in healthy volunteers.
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Incyte Announces U.S. Food and Drug Administration Grants Priority Review for Axatilimab for the Treatment of Chronic Graft-Versus-Host Disease
2/27/2024
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for axatilimab, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy.
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Syndax Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Clinical and Business Update
2/27/2024
Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the fourth quarter and full year ended December 31, 2023, and provided a clinical and business update.
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Neurona Therapeutics will use the funds to advance its investigational regenerative neural cell therapy NRTX-1001 for mesial temporal lobe epilepsy, the most common form of focal epilepsy.
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Neurona Therapeutics Raises $120M to Advance Groundbreaking Pipeline of Regenerative Cell Therapy Candidates for Chronic Neurological Disorders
2/8/2024
Neurona Therapeutics today announced the successful completion of a $120 million financing co-led by Viking Global Investors and Cormorant Asset Management with participation from new and existing investors.
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The two biopharmaceutical industry organizations entered Medicare price negotiations after the loss of several prominent members and executives.
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Acadia Announces the Passing of Former President Srdjan (Serge) Stankovic
1/18/2024
Acadia Pharmaceuticals Inc. is saddened to announce the passing of its former President, Srdjan Stankovic M.D., M.S.P.H. Serge passed away peacefully on December 29, 2023, following a prolonged illness.
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Mirum Pharmaceuticals Appoints Joanne Quan, MD as Chief Medical Officer
1/16/2024
Mirum Pharmaceuticals, Inc., announced the appointment of Joanne Quan, MD as Chief Medical Officer. Dr. Quan will lead the global clinical development, clinical operations, and safety programs for Mirum’s pipeline of programs addressing rare diseases.
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ExeVir Bio Announces Positive Virus Neutralization Data for XVR012 Against Emerging COVID-19 Omicron Variants
1/15/2024
ExeVir Bio announced new data demonstrating that its antibodies are highly potent in neutralizing currently circulating COVID-19 Omicron variants.
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PANTHERx® Rare Selected by UCB as the Exclusive Specialty Pharmacy for ZILBRYSQ® (zilucoplan) for the Treatment of Generalized Myasthenia Gravis (gMG) in Adult Patients Who Are Anti-Acetylcholine Receptor (AChR) Antibody Positive
1/10/2024
PANTHERx® Rare, a leader in rare disease product patient access and support services in the United States, is pleased to announce that it was selected by UCB to dispense ZILBRYSQ®, a new FDA-approved therapy for the treatment of adults with gMG who are anti-AChR antibody positive.
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Capstan Therapeutics Appoints Ramin Farzaneh-Far, M.D., as Chief Medical Officer and Announces Key Business Leadership Promotion
1/8/2024
Capstan Therapeutics, Inc. announced the appointment of Ramin Farzaneh-Far, M.D., as Chief Medical Officer and the promotion of Miguel Arcinas to Senior Vice President, Corporate Development.