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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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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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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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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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SpecialtyVETPATH Taps Proscia For A Full Transformation Of Its Pathology Operations
4/23/2024
SpecialtyVETPATH, a private, pathologist-owned, and pathologist-directed veterinary pathology laboratory, has selected Proscia®, a leading provider of digital and computational pathology solutions
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Lipid Nanoparticles (LNPs) CDMO Market to Reach USD 518.2 Million with a CAGR of 14.10% from 2024-2031
4/23/2024
Global Lipid Nanoparticles (LNPs) CDMO Market in terms of revenue was predicted to be worth $182.0 Mn in 2023 and is poised to reach 518.2 Mn by 2031, increasing at a CAGR of 14.10% from 2024 to 2031.
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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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SAIL Fusion Announces FDA Clearance of its BowTie™ Sacroiliac Fusion System
4/23/2024
SAIL Fusion, a medical device company focused on advancing the surgical treatment of sacroiliac joint dysfunction through solutions built upon proven AO principles, today announced that it has received FDA clearance for its novel BowTie Sacroiliac Fusion System.