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An FDA advisory committee this week voted overwhelmingly against BrainStorm Cell Therapeutics’ amyotrophic lateral sclerosis treatment. However, other potential therapies offer hope for ALS patients.
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Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
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Pivotal clinical trials in Alzheimer’s disease, Huntington’s disease, amyotrophic lateral sclerosis and multiple sclerosis are expected to read out this fall. Here's a closer look.
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Keep up with the regulator's latest rulings on novel drugs and expanded indications, as the second half of 2023 promises some major milestone FDA approvals.
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Thursday’s approval comes after the FDA pushed back the target action dates for Amicus’ Biologics License Application in May, allowing the regulator more time to review the company’s submitted data.
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New Analysis Highlights Importance of Adhering to Uninterrupted Full Course of Treatment with TEPEZZA® (teprotumumab-trbw) to Support Thyroid Eye Disease (TED) Patient Outcomes
9/29/2023
Horizon Therapeutics plc (Nasdaq: HZNP) today announced new data showing that disrupting the recommended TEPEZZA treatment regimen by lengthening the amount of time between infusions can increase the need for a second course of treatment.
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Atamyo Therapeutics Announces participation in Conferences and Key Scientific Communications on its LGMD programs
9/29/2023
Atamyo Therapeutics announced its participation to forthcoming conferences and scientific communications on its programs targeting limb-girdle muscular dystrophies.
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XORTX Sponsored Study Selected for Presentation at the American Society of Nephrology – Kidney Week 2023
9/28/2023
XORTX Therapeutics Inc., a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce the acceptance of an abstract submitted to the American Society of Nephrology.
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Cytokinetics Announces Call for Proposals for Its Sixth Annual Communications Grant Program
9/28/2023
Cytokinetics, Incorporated announced a call for proposals for the sixth annual Cytokinetics Communications Grant Program.
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Amicus Therapeutics Announces FDA Approval and Launch of New Treatment for Pompe Disease
9/28/2023
Amicus Therapeutics (Nasdaq: FOLD) today announced that the U.S. Food and Drug Administration (FDA) has approved Pombiliti™ (cipaglucosidase alfa-atga) + Opfolda™ (miglustat) 65mg capsules.
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Basilea announces New England Journal of Medicine publication of phase 3 data on ceftobiprole for the treatment of Staphylococcus aureus bacteremia
9/28/2023
Basilea Pharmaceutica Ltd, Allschwil announced that data from the successful phase 3 study ERADICATE were published in the New England Journal of Medicine, one of the world's leading peer-reviewed medical journals.
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BrainStorm Cell Therapeutics Provides Update on FDA Advisory Committee Meeting to Review NurOwn for the Treatment of ALS
9/28/2023
BrainStorm Cell Therapeutics Inc. announced the outcome of the U.S. Food and Drug Administration's Cellular, Tissue and Gene Therapies Advisory Committee meeting to review the Biologics License Application for NurOwn®, an investigational mesenchymal stem cell therapy for the treatment of amyotrophic lateral sclerosis.
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SGC and HitGen Announce Research Collaboration Focused on DNA-Encoded Library Based Drug Discovery
9/28/2023
Shanghai Stock Exchange listed company HitGen Inc. announced that it has entered into a partnership with The Structural Genomics Consortium, a public-private partnership that supports the discovery of new medicines through open-access research.
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Novel iTind Procedure Now Included in Treatment Guideline for Lower Urinary Tract Symptoms Caused by Enlarged Prostate
9/28/2023
Olympus Corporation announced that its iTind™ procedure is now included in the American Urological Association clinical practice guideline for management of lower urinary tract symptoms attributed to benign prostatic hyperplasia, also known as enlarged prostate.
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X-Chem and Structural Genomics Consortium Enter Into Collaboration to Unlock the Human Proteome and Promote Open Science
9/28/2023
X-Chem, a global leader in innovative drug discovery services, and the Structural Genomics Consortium, a public-private partnership dedicated to accelerating drug discovery through open science, announced that they have entered a collaboration aimed at creating new chemical tools to study human proteins.
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Naveris Announces New Data Featuring NavDx® in Oral Highlight and Poster Presentations at Upcoming ASTRO and AAO-HNSF 2023 Meetings
9/28/2023
Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, announced that the company will be attending The American Academy of Otolaryngology-Head and Neck Surgery 2023 Annual Meeting in Nashville, Tenn., from September 30-October 4 and The American Society for Radiation Oncology 2023 Annual Meeting in San Diego, Calif., from October 1-4.
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Ascletis Announces Positive Interim Data from the Phase IIb Expansion Cohort of ASC22 (Envafolimab) for Chronic Hepatitis B Functional Cure
9/28/2023
Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announces positive interim data from the Phase IIb expansion cohort (the "Expansion Cohort") of subcutaneously administered PD-L1 antibody ASC22 (Envafolimab) for functional cure of chronic hepatitis B (CHB).
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Clene Announces Peer-Reviewed Publication Describing CNM-Au8 Catalytic Neuroprotective Mechanism of Action
9/28/2023
Clene Inc. (Nasdaq: CLNN) through its wholly owned subsidiary Clene Nanomedicine Inc. (collectively, “Clene”), today announced the publication of a scientific paper describing the catalytic mechanism of action of its investigational drug CNM-Au8® in the journal Small, a top nanotechnology-focused journal at the interface of materials science, chemistry, physics, engineering, medicine, and biology.
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An FDA advisory committee voted 17-1 on Wednesday that BrainStorm Cell Therapeutics did not demonstrate substantial evidence of efficacy for NurOwn in mild to moderate amyotrophic lateral sclerosis.
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While Astellas did not say why it withdrew its suit, it was the only company to file a legal complaint that wasn’t on the initial IRA drug price negotiations list and may not have had any grounds to sue.