Business Wire
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Shorla Oncology Announces FDA Filing Acceptance Of New Drug Application To Treat Certain Forms Of Leukemia And Other Cancers
4/8/2024
Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for SH-201, the first palatable oral liquid of the related chemotherapeutic agent to treat certain forms of leukemia and other cancers.
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Aurigene Pharmaceutical Services Ltd. Introduces Aurigene.AI, An Artificial Intelligence (AI) And Machine Learning (ML) Assisted Drug Discovery Platform
4/3/2024
Aurigene Pharmaceutical Services Limited (Aurigene), a contract research, development, and manufacturing services organization and a Dr. Reddy’s Laboratories company, introduces Aurigene.AI, an AI and ML-assisted platform for accelerating drug discovery projects from hit identification to candidate nomination.
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Mosaic Biosciences Expands Its Leading Drug Discovery And Development Expertise
4/2/2024
Mosaic Biosciences, a drug discovery organization that provides comprehensive protein and antibody therapeutics research expertise to its biotech, biopharma, and academic partners, today announced two strategic leadership additions to its team: Malavi Madireddi, PhD, as Senior Vice President, Drug Discovery, and Scott Glaser, PhD, as Senior Vice President, Biologics Discovery. Both recognized leaders join the company as it grows to meet increased demand for its comprehensive and integrated drug discovery research services.
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Otsuka And Click Therapeutics Announce The U.S. Food And Drug Administration (FDA) Clearance Of Rejoyn, The First Prescription Digital Therapeutic Authorized For The Adjunctive Treatment Of Major Depressive Disorder (MDD) Symptoms
4/1/2024
Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Click Therapeutics, Inc., (Click) announce that the U.S. Food and Drug Administration (FDA) has cleared Rejoyn (developed as CT-152), the first prescription digital therapeutic authorized for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD age 22 years and older who are on antidepressant medication. Rejoyn is intended to reduce MDD symptoms.
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Synthekine Announces U.S. FDA Clearance Of IND Application For CD19 CAR-T And Orthogonal IL-2 Combination Therapy, SYNCAR-001 + STK-009, For Treatment Of Lupus Without Lymphodepletion
3/26/2024
Synthekine Inc., an engineered cytokine therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to evaluate SYNCAR-001 + STK-009, its orthogonal IL-2 and CD19 CAR-T combination therapy, in patients with non-renal systemic lupus erythematosus (SLE) and lupus nephritis (LN), without the use of any lymphodepletion.
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CinFina Pharma Announces FDA Clearance Of Investigational New Drug Application And First Participants Dosed In Phase 1 Trial Of CIN-110 For The Treatment Of Obesity
3/26/2024
CinFina Pharma, a CinRx portfolio company dedicated to advancing a portfolio of high-impact treatment options for obesity and metabolic diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug Application (IND) for CIN-110, aPYY3-36analog, allowing the first in-human clinical study to proceed.
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Teva UK And Closed Loop Medicine Announce Strategic Partnership To Advance Development Of Personalised Medicines
3/26/2024
Teva UK Limited and Closed Loop Medicine Ltd have announced a strategic partnership to advance the development of personalised medicines.
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Ubiquigent And Debiopharm Enter Agreement To Support USP1 Inhibitor Programme For Debio 0432
3/26/2024
Ubiquigent Limited (Ubiquigent), a drug discovery and development company harnessing novel deubiquitinase (DUB) modulators as new therapeutics for areas of high unmet medical need, today announced an agreement with Debiopharm, a biopharmaceutical company aiming to develop tomorrow’s standard-of-care treatments to cure cancer and infectious diseases.
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Amneal Receives U.S. FDA Approval For Ciprofloxacin And Dexamethasone Otic Suspension
3/25/2024
Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension.
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Biocytogen Enters Collaboration With ABL Bio To Develop New Bispecific Antibody-Drug Conjugates
3/25/2024
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, and ABL Bio Inc. a Korean clinical-stage biotechnology company developing novel therapeutics in oncology and CNS diseases, today announced a collaboration to develop new bispecific antibody-drug conjugates (bsADCs).