Product News

Found 259,217 articles

• TG Therapeutics Announces Positive CHMP Opinion for BRIUMVI™ (ublituximab-xiiy) for the Treatment of Relapsing Forms of Multiple Sclerosis in Adults

  3/31/2023

  TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of BRIUMVI™ (ublituximab-xiiy) for the treatment of adult patients relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

• Cabaletta Bio Receives FDA Clearance of IND Application for CABA-201 for Treatment of Systemic Lupus Erythematosus

  3/31/2023

  Cabaletta Bio, Inc. (Nasdaq: CABA) today announced that the Company’s Investigational New Drug (IND) application for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, has been cleared by the U.S. Food and Drug Administration (FDA).

• Nexcella, an Immix Biopharma Subsidiary, Announces 2023 Haematologica Editorial Highlighting NXC-201 Efficacy In The Context of U.S. Food And Drug Administration Approved BCMA CAR T Cells

  3/31/2023

  Nexcella, Inc. today announced that an editorial written by Maria Sjöstrand and Michel Sadelain of Memorial Sloan Kettering Cancer Center was published 2023 in Haematologica highlighting NXC-201 in the context of the current U.S. Food And Drug Administration (“FDA”) approved BCMA CAR-T Cell therapies.

• Nexcella Announces 2023 Haematologica Editorial Highlighting NXC-201 Efficacy In The Context of U.S. Food And Drug Administration Approved BCMA CAR T Cells

  3/31/2023

  Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”) today announced that an editorial written by Maria Sjöstrand and Michel Sadelain of Memorial Sloan Kettering Cancer Center was published 2023 in Haematologica highlighting NXC-201 in the context of the current U.S. Food And Drug Administration (“FDA”) approved BCMA CAR-T Cell therapies.

• Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy

  3/31/2023

  Bristol Myers Squibb (NYSE: BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL).

• Fennec Pharmaceuticals Receives Positive CHMP Opinion for Pedmarqsi™ (sodium thiosulfate) to Reduce the Risk of Hearing Loss in Pediatric Oncology Patients

  3/31/2023

  Fennec Pharmaceuticals Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion and recommended granting a Marketing Authorization for Pedmarqsi™ (sodium thiosulfate) – known as PEDMARK® in the U.S. – for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to <18 years of age with localized, non-metastatic, solid tumors.

• CMP Pharma's Potassium Phosphates Injection Receives FDA Shelf Life Extension for Specific Lots

  3/31/2023

  CMP Pharma announced today that in order to mitigate drug shortage concerns, the FDA's CDER Office of Compliance has granted a shelf life extension for CMP Development LLC Potassium Phosphates Injection (NDA 212121).

• Ablaze Pharmaceuticals Plans Development of Innovative GPC3 Targeted Radiopharmaceutical Therapy for Liver Cancer in Greater China

  3/31/2023

  Ablaze Pharmaceuticals, a biotech company that is focused on developing Targeted Radiotherapy (TRT) to benefit cancer patients in China, today announced the development plans of a first-in-class novel peptide drug candidate against GPC3.

• Genscript Biotech Reports 2022 Annual Results*

  3/31/2023

  GenScript Biotech, the world's leading biotech company, announces its annual results as of December 31, 2022.

• Eledon Reports Data from Ongoing Phase 1b Trial Evaluating Tegoprubart in Patients Undergoing Kidney Transplantation at World Congress of Nephrology

  3/31/2023

  Eledon Pharmaceuticals, Inc. reported results from the Company’s ongoing Phase 1b open-label trial evaluating tegoprubart in patients undergoing kidney transplantation at the World Congress of Nephrology, which is taking place March 30 to April 2, 2023.

• Tianlong Announces Global Release of GeneFlex Nucleic Acid Extractor and Gentier mini+ Real-time PCR System

  3/31/2023

  Tianlong, an innovative high-tech company specializing in molecular diagnostic products, has announced the global release of two new products, the GeneFlex Nucleic Acid Extractor and the Gentier mini+ Real-time PCR System.

• NovelStem, Focused on a Patented Genetic Platform Technology for Anti-Cancer Therapies, Reports 2022 Results on Form 10-K

  3/31/2023

  Boca Raton, Florida--(Newsfile Corp. - March 31, 2023) - NovelStem International Corp. (OTC Pink: NSTM), a development-stage company focused on the stem cell-based technology platform developed by Israel-based NewStem Ltd., today filed its Form 10-K for the year ended December 31, 2022. NovelStem owns a 30.58% equity interest in NewStem Ltd.

• RAYUS Radiology Introduces New State-of-the-Art CT Scanner Utilizing Photon-Counting Technology

  3/31/2023

  RAYUS Radiology has bolstered its line of high-end imaging technology solutions with the installation of the new NAEOTOM Alpha® CT scanner from Siemens Healthineers at its Palm Beach Gardens, Florida location – the first CT scanner of its kind serving patients in South Florida.

• Ad Astra Diagnostics files 510(k) for QScout™ hematology analyzer

  3/30/2023

  Ad Astra Diagnostics, developer of rapid diagnostic systems, announced that it has submitted a 510 application to the U.S. Food and Drug Administration for its QScout RLD rapid-result hematology system intended to report white blood cell count, neutrophil-to-lymphocyte ratio, and counts of six white blood cell types in fingerstick or venous blood.

• EIP Pharma and Diffusion Pharmaceuticals Announce Merger Agreement to Create Leading CNS-focused Company Treating Neurodegenerative Diseases

  3/30/2023

  EIP Pharma Inc. and Diffusion Pharmaceuticals Inc., announced that the companies have entered into a definitive merger agreement for an all-stock transaction forming a publicly traded, combined company that will focus on the advancement of EIP Pharma’s pioneering pipeline of oral stress kinase inhibitors, including its lead drug candidate neflamapimod, which is currently being developed for the treatment of dementia with Lewy bodies.

• Psilera Eyes Non-Hallucinogenic Drug Candidates for First-in-Human Studies

  3/30/2023

  Psilera is proud to achieve a landmark preclinical milestone with 100% success.

• Immutep Announces Expansion of Triple Combination Therapy in 1st Line Non-Small Cell Lung Cancer

  3/30/2023

  Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”) today announces it has signed an agreement to expand the INSIGHT-003 trial evaluating the combination of eftilagimod alpha (“efti”), a soluble LAG-3 protein and first-in-class MHC class II agonist, in conjunction with standard-of-care combination of anti-PD-1 therapy and chemotherapy in 1st line non- small cell lung cancer (1L NSCLC).

• Allogene Therapeutics Publishes 2022 Annual Environmental, Social and Governance (ESG) Report

  3/30/2023

  Allogene Therapeutics, Inc., a clinical-stage biotechnology company pioneering the development of allogeneic CAR T products for cancer, published its 2022 annual ESG report.

• Inventiva announces filing of its 2022 Universal Registration Document and 2022 Annual Report on Form 20-F

  3/30/2023

  Inventiva announced that it had filed its 2022 Universal Registration Document for the year ended December 31, 2022, including the management report and the annual financial report, with the French “Autorité des Marchés Financiers” and its 2022 Annual Report on Form 20-F for the year ended December 31, 2022 with the U.S.

• OncoRix's breast cancer integrative solution demonstrated enhanced efficacy when combined with chemotherapy in an ex-vivo model

  3/30/2023

  Cannabotech (TASE: CNTC), a biotechnology company that developed OncoRix – an integrative oncology brand, based on Cannabis and functional mushroom extracts, published the results of its study using an ex-vivo model to test its anticancer efficacy on breast cancer tissues.