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Policy changes by health insurance companies will likely determine which Humira biosimilars rise to the top.
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Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
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The Swiss drugmaker raised its full-year guidance Tuesday projecting net sales to grow in the high-single to low double-digit range while reporting better-than-expected first-quarter results.
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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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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 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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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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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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Ionis to hold first quarter 2024 financial results webcast
4/23/2024
Ionis Pharmaceuticals, Inc. announced that it will host a live webcast on Tuesday, May 7th at 11:30 a.m. Eastern Time to discuss its first quarter 2024 financial results.
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Nu.Q® Vet Cancer Test launched in-clinic in U.S. and Europe through Antech
4/23/2024
VolitionRx Limited has announced that its Nu.Q® Vet Cancer Test is now available in-clinic to veterinarians across the U.S and Europe through Antech, a leading veterinary diagnostics company.
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Regeneration Biomedical Doses First Patient in a First-in-Human Phase I Clinical Trial of Stem Cell Therapy delivered directly into the brain of Patients with Alzheimer’s Disease
4/23/2024
Regeneration Biomedical, Inc. announced that the first patient has been dosed in an FDA-cleared, first-in-human Phase 1 clinical trial of autologous, Wnt-Activated Adipose-Derived Stem Cells for patients with mild-to-moderate Alzheimer’s disease.
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Tiziana Life Sciences Announces FDA Allowance for Additional Twenty Patients to be Enrolled in the Intranasal Foralumab Multiple Sclerosis Expanded Access Program
4/23/2024
Tiziana Life Sciences, Ltd. announced that the U.S. Food and Drug Administration has allowed its intranasal foralumab non-active Secondary Progressive Multiple Sclerosis Expanded Access Program to expand from 10 patients to a total of 30 patients.
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Skye Bioscience to Present at Upcoming Investment Conferences - April 23, 2024
4/23/2024
Skye Bioscience, Inc. announced that Chief Executive Officer & Chair Punit Dhillon and other members of Skye’s executive team will present the company and its programs in obesity and glaucoma at the following investment conferences.
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Revive Therapeutics Announces Type C Meeting Request Granted by FDA for Clinical Study of Bucillamine to Treat Long COVID
4/23/2024
Revive Therapeutics Ltd. announced that the U.S. Food & Drug Administration has granted the Company’s Type C meeting request for the evaluation of a proposed clinical study of Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties, as a potential treatment for long COVID.
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LSL Pharma Group Announces the Addition of New Members to Its Board of Directors
4/23/2024
LSL PHARMA GROUP INC. announced the appointment of Diane Beaudry and Mario Paradis to its Board of Directors.
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Day One’s OJEMDA™ (tovorafenib) Receives US FDA Accelerated Approval for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG), the Most Common Form of Childhood Brain Tumor
4/23/2024
Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved OJEMDA (tovorafenib), a type II RAF inhibitor, for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
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Astellas' XTANDI™ (Enzalutamide) Granted European Commission Approval for Use in Additional Recurrent Early Prostate Cancer Treatment Setting
4/23/2024
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the European Commission (EC) has approved a label extension for XTANDI™ (enzalutamide) as monotherapy or in combination with androgen deprivation therapy (ADT) for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy.
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Clarapath Forms Strategic Collaboration with Mayo Clinic to Advance Pathology Tissue Processing
4/23/2024
Clarapath, a medical robotics company transforming the way pathology laboratories process tissue, announced it has entered into a strategic collaboration with Mayo Clinic to propel a new era of laboratory automation.