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IASO Bio Announces NMPA's IND Approval for Equecabtagene Autoleucel in Second- and Third-Line Treatment of Multiple Myeloma
3/29/2024
IASO Bio announced that China National Medical Products Administration has approved the Investigational New Drug application for Equecabtagene Autoleucel, a self-developed fully-human anti-B cell maturation antigen chimeric antigen receptor autologous T-cell injection, for an expanded indication in treating relapsed and/or refractory multiple myeloma patients who have undergone 1-2 lines of prior therapies and are refractory to lenalidomide.
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Junshi Biosciences Announces 2023 Full Year Financial Results and Provides Corporate Updates
3/29/2024
Shanghai Junshi Biosciences Co., Ltd, announced its financial results for the full year of 2023 and provided corporate updates.
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Keytruda can now be used in the European Union for patients with resectable non-small cell lung cancer at high risk of recurrence in combination with platinum chemotherapy, then continued as a monotherapy afterwards.
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Syndax Announces Completion of Enrollment in AUGMENT-101 Pivotal Trial Cohort of Patients with Relapsed/Refractory mNPM1 Acute Myeloid Leukemia
3/28/2024
Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced completion of enrollment in the AUGMENT-101 pivotal trial cohort of patients with relapsed/refractory (R/R) mutant nucleophosmin (mNPM1) acute myeloid leukemia (AML).
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InterSystems and IPA’s Subsidiary BioStrand Collaborate to Unveil the Innovative Integration of Vector Search with LENSai for AI-Driven Healthcare Applications
3/28/2024
IPA, InterSystems, a creative data technology provider dedicated to helping customers solve their most critical scalability, interoperability, and speed challenges, together with ImmunoPrecise Antibodies Ltd., an artificial intelligence-driven biotherapeutic research and technology company, are thrilled to announce a landmark collaboration.
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HUTCHMED Announces Savolitinib sNDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC
3/28/2024
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the supplemental New Drug Application (“sNDA”) for savolitinib, in adult patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) with mesenchymal epithelial transition factor (“MET”) exon 14 skipping alteration, has been accepted for review by the China National Medical Products Administration (NMPA).
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Ginkgo Bioworks Awarded DARPA Funding to Produce Novel Proteins to Control Ice in Extreme Cold Weather Environments
3/28/2024
Ginkgo Bioworks announced that it has been awarded a contract for up to $6 million from the Defense Advanced Research Projects Agency to achieve DARPA's objectives under its new Ice Control for cold Environments program.
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JenaValve Announces Publication of ALIGN-AR Pivotal Trial Results in The Lancet
3/28/2024
JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced the publication of results from the ALIGN-AR Pivotal Trial in The Lancet.
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Mustang Bio Announces Vision for CAR T-Cell Therapy Platform Expansion into Autoimmune Diseases
3/28/2024
Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced its expansion into autoimmune diseases with MB-106, a personalized CD20-targeted, 3rd-generation autologous CAR T-cell therapy.
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Ionis to hold olezarsen Phase 3 data webcast
3/28/2024
Ionis Pharmaceuticals, Inc. announced that it will host a live webcast on Monday, April 8th at 10:00 a.m. Eastern Time to discuss the olezarsen Phase 3 Balance study results in patients with familial chylomicronemia syndrome presented at the 2024 American College of Cardiology Annual Meeting.
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C-Path Launches Clinical Trial Simulator for Duchenne Muscular Dystrophy Research
3/28/2024
Critical Path Institute's (C-Path) Duchenne Regulatory Science Consortium (D-RSC) is excited to announce the launch of a groundbreaking model-based Clinical Trial Simulator (CTS), specifically designed to improve design of efficacy studies for potential therapies for Duchenne muscular dystrophy (DMD).
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Serum Detect Launches with Novel T-Cell Analysis Approach for Cancer Early Detection at AACR
3/28/2024
Serum Detect, a cancer diagnostics company, is debuting a novel and promising approach for cancer early detection at the upcoming American Association for Cancer Research (AACR) conference.
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Apollomics Highlights Clinical Progress and Reports Full Year 2023 Financial Results
3/28/2024
Apollomics Inc. announced financial results for the full year ended December 31, 2023, and highlighted progress of its pipeline.
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China's National Medical Products Administration Accepts Astellas and Pfizer's Supplemental Biologics License Application for enfortumab vedotin with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer
3/28/2024
Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") today announced that on March 27, 2024 the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the supplemental Biologics License Application (sBLA) for enfortumab vedotin with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).
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Nested Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for NST-628, a Novel Pan-RAF/MEK Molecular Glue
3/28/2024
Nested Therapeutics today announced that the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for NST-628 for the treatment of patients with advanced solid tumors harboring genetic alterations in the RAS-MAPK pathway.
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Kraig Biocraft Laboratories Shares Industry Update on Recombinant Spider Silk from Waste Plastics
3/28/2024
Kraig Biocraft Laboratories, Inc., comments on an exciting advancement in spider silk engineering from the Rensselaer Polytechnic Institute.
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Milestone Pharmaceuticals Announces Resubmission of New Drug Application for Etripamil for Treatment in Paroxysmal Supraventricular Tachycardia
3/28/2024
Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for etripamil, the Company’s lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT).
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Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia
3/28/2024
Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for govorestat (AT-007) for the treatment of Classic Galactosemia by three months.
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Broncus Medical (02216.HK) Announces Annual Results for 2023
3/28/2024
In 2023, Broncus Medical earned product sales of US$12.41 million, an increase of 32% compared to the previous year.
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Viva Biotech (1873.HK) Announces 2023 Annual Results: Successful Implementation of Light-asset Strategy, Achieving Solid Growth and Promising Future
3/28/2024
On March 28, 2024, Viva Biotech Holdings Group announced that the Group's revenue during the Reporting Period achieved RMB2,155.6 million; and our gross profit amounted to RMB738.5 million.