Pharmaceuticals
NEW THERAPY FOR CHILDREN WITH GROWTH HORMONE DEFICIENCY APPROVED IN AUSTRALIA
SKYTROFA® (lonapegsomatropin) is now registered by the Therapeutic Goods Administration (TGA) for the treatment of paediatric growth hormone deficiency.[ 1] SINGAPORE, May 29, 2025 /PRNewswire/ -- Independent biopharmaceutical company Specialised Therapeutics (ST) is pleased to announce the Austr...
2025-05-30 00:01
2339
First patient imaged in Phase III AMPLIFY trial with 64Cu-SAR-bisPSMA PET/CT
SYDNEY, May 29, 2025 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce that it has imaged the...
2025-05-29 21:04
2031
Medicilon Passes FDA Inspection, Reinforcing Global R&D Excellence
BOSTON, May 29, 2025 /PRNewswire/ -- On May 20, Medicilon Preclinical Research ( Shanghai) LLC ("Medicilon") announces that it has successfully passed an on-site inspection by the FDA. The company receives an official Establishment Inspection Report (EIR) reaffirming its position as a trusted lead...
2025-05-29 20:30
1697
AccurEdit Therapeutics' ART001 Becomes China's First Gene Editing Therapy to Receive FDA Regenerative Medicine Advanced Therapy (RMAT) Designation
RMAT designation expected to expedite development; 72 weeks interim clinical trial data showing sustainable reduction of TTR over 90% with no significant adverse events. SUZHOU, China, May 29, 2025 /PRNewswire/ -- AccurEdit Therapeutics today announced that its internally developed in vivo gene ...
2025-05-29 20:00
1746
Neuronata-R® Stem Cell Therapy Shows Promise in ALS Phase 3 Subgroup Analysis, Moves Toward FDA Accelerated Approval
Meaningful efficacy observed in slow-progressor subgroup; NfL biomarker improvements support potential for accelerated regulatory pathway SEOUL, South Korea, May 29, 2025 /PRNewswire/ -- Neuronata-R®, an autologous bone marrow-derived mesenchymal stem cell (MSC) therapy for amyotrophic lateral s...
2025-05-29 20:00
2346
Kexing Biopharm's GB18 project received clearance of IND application from NMPA and FDA
SHENZHEN, China, May 28, 2025 /PRNewswire/ -- On May 26th, Kexing Biopharm (688136.SH) announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its independently developed innovative product, GB18. Moreover, GB18 has previo...
2025-05-29 11:47
1551
Formosa Pharmaceuticals and Adalvo Limited Announce Licensing Agreement for Clobetasol Propionate Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain
TAIPEI, May 28, 2025 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TW) announced that the company has entered into an exclusive licensing agreement with Adalvo Limited ("Adalvo") in the European and Brazilian markets for exclusive rights to the commercialization of clobeta...
2025-05-28 20:00
2308
CARsgen's Satri-cel Granted Priority Review by the NMPA
SHANGHAI, May 28, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the Center for Drug Evaluation (CDE) ofChina's National Medical Products Administration (NMPA) has granted Priority R...
2025-05-28 12:10
2012
Dizal to Highlight its Portfolio Advances in Hematologic Malignancies and Lung Cancer at ASCO 2025
* DZD8586 demonstrated significant anti-tumor efficacy in heavily pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients with ORR of 84.2% * DZD6008, a BBB-penetrant 4th generation EGFR TKI, showed encouraging and durable anti-tumor activity with favorable safet...
2025-05-26 18:06
2187
Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths
* YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar[1] * Celltrion previously received interchangeability (IC) designation for YUFLYMA® (adalimumab-aaty) in prefilled syringes (20mg & 80mg); Expanded interchangeabilit...
2025-05-24 01:47
4327
/DISREGARD RELEASE: Celltrion/
We are advised by Celltrion that journalists and other readers should disregard the news release, Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths, issued21-May-2025 over PR Newswire. ...
2025-05-24 00:01
4239
Mabwell Announces Clinical Data of Multiple ADCs to be presented at 2025 ASCO Annual Meeting
SHANGHAI, May 23, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced multiple clinical research results to be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, including phase Ib/II clini...
2025-05-23 22:00
4312
UniXell Biotechnology announces the first patient dosed with UX-DA001, an investigational autologous iPSC based cell therapy for the treatment of Parkinson's disease, in its Phase 1 study
SHANGHAI, May 23, 2025 /PRNewswire/ -- Shanghai UniXell Biotechnology Co., Ltd. (UniXell Biotech), a biotech company dedicated to innovative cell therapies, announced the successful first administration of its proprietary Parkinson's disease cell drug UX-DA001 inChina in March 2025. The Phase I c...
2025-05-23 19:18
4841
Nona Biosciences Collaboration Partner Pfizer Announces Presentation of Phase 1 Clinical Study Design on MesoC2, an MSLN-Targeting ADC, at the 2025 ASCO Annual Meeting
CAMBRIDGE, Mass., May 23, 2025 /PRNewswire/ -- Nona Biosciences, a global biotechnology company providing integrated solutions from "Idea to IND" (I to I TM), today announced that its collaborator, Pfizer, will present an abstract detailing the first-in-human Phase 1 clinical study design of MesoC...
2025-05-23 12:21
3308
FDA Clearance of Investigational New Drug Application Received for Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418/DB-1418
Phase 1/2 first-in-human clinical study planned this year SHANGHAI and SAN DIEGO, May 22, 2025 /PRNewswire/ -- Duality Biotherapeutics ("DualityBio", HKEX:09606) partner Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, to...
2025-05-23 10:44
2282
Eisai to Present E7386, Co-created by PRISM BioLab and Eisai, at the ASCO (American Society of Clinical Oncology) Annual Meeting
Abstract Released for E7386, Co-Developed Through Collaborative Research Between Eisai and PRISM TOKYO, May 22, 2025 /PRNewswire/ -- PRISM BioLab, Co. Ltd. ("PRISM"), a leading discovery and development biotechnology company designing small molecule inhibitors of protein-protein interaction (PPI...
2025-05-23 08:00
3409
CARsgen's Satri-cel Abstract Available on ASCO Website
SHANGHAI, May 22, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that an abstract of the research results of the confirmatory Phase II clinical trial of satricabtagene autoleucel ("satri-...
2025-05-23 08:00
2209
Porton Advanced Announces Collaboration with TongEYE to Accelerate Development of iPSC-RPEC transplantation therapy
SUZHOU, China, May 22, 2025 /PRNewswire/ -- Porton Advanced, a leading contract development and manufacturing organization (CDMO) specializing in advanced therapy medicinal products (ATMPs), is pleased to announce its partnership with TongEye Medical Technology (TongEYE), an innovator focusing on...
2025-05-22 21:00
2155
BioDlink Clinches Brazil GMP Audit to Strengthen Emerging Markets Growth
* International recognition of quality system with GMP-compliance in the key markets ofBrazil, Indonesia, Egypt, Colombia and Argentina * Passed its first-ever on-site PIC/S audit, reinforcing its strong commitment to stringent international regulatory standards * Demonstrated BioDlink's cap...
2025-05-21 20:30
2142
SK bioscience Wins Patent Lawsuit Against Pfizer Over Pneumococcal Vaccine
* No patent infringement found in exports of individual conjugate bulk substances and research-use finished products of PCV13 toRussia * Company plans to export PCV13 vaccine components * "We aim for the global PCV market with our 21-valent and next-generation pneumococcal vaccines currently...
2025-05-21 20:00
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