Nuance Pharma Announces Acceptance for Review of the New Drug Application for Ohtuvayre® (ensifentrine) by the National Medical Products Administration of China for the maintenance treatment of chronic obstructive pulmonary disease

Nuance Pharma Announces Acceptance for Review of the New Drug Application for Ohtuvayre® (ensifentrine) by the National Medical Products Administration of China for the maintenance treatment of chronic obstructive pulmonary disease

SHANGHAI, Jan. 27, 2026 /PRNewswire/ -- Nuance Pharma ("Nuance") today announced that the National Medical Products Administration (NMPA) of China has officially accepted for review the New Drug Application (NDA) for Ohtuvayre ® (ensifentrine) for...

Landmark FDA Move: First Quality Control Protocol for Mesenchymal Stromal Cells (MSCs) Sets New Therapeutic Standard

Landmark FDA Move: First Quality Control Protocol for Mesenchymal Stromal Cells (MSCs) Sets New Therapeutic Standard

TIANJIN, China, Jan. 26, 2026 /PRNewswire/ -- In a landmark move for the cell therapy industry, a Device Master File (DMF) describing the first dedicated quality control standard for Mesenchymal Stromal Cells (MSCs) was accepted by the U.S. Food and...

Akeso Announces NMPA Acceptance of Second NDA for Gumokimab (IL-17A Inhibitor) in Active Ankylosing Spondylitis

Akeso Announces NMPA Acceptance of Second NDA for Gumokimab (IL-17A Inhibitor) in Active Ankylosing Spondylitis

HONG KONG, Jan. 19, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) announced that its supplemental New Drug Application (sNDA) for gumokimab (AK111), a novel humanized anti-IL-17A monoclonal antibody for the treatment of active ankylosing spondylitis...

Belief BioMed Congratulates Partner AskBio on IND Acceptance by FDA for Investigational Gene Therapy for Late-Onset Pompe Disease

Belief BioMed Congratulates Partner AskBio on IND Acceptance by FDA for Investigational Gene Therapy for Late-Onset Pompe Disease

SHANGHAI, Jan. 15, 2026 /PRNewswire/ -- AskBio Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, recently announced that the United States Food and Drug Administration (FDA) has accepted its...

Alphamab Oncology Announces IND Application for a Phase II Clinical Study of HER2 Bispecific ADC Subcutaneous Co-formulation JSKN033 as First-line Treatment of Advanced Cervical Cancer was Officially Accepted by CDE

Alphamab Oncology Announces IND Application for a Phase II Clinical Study of HER2 Bispecific ADC Subcutaneous Co-formulation JSKN033 as First-line Treatment of Advanced Cervical Cancer was Officially Accepted by CDE

SUZHOU, China, Dec. 29, 2025 /PRNewswire/ -- Alphamab Oncology (Stock Code: 9966.HK) announced that the IND application for a Phase II clinical study of JSKN033 (a proprietary high-concentration subcutaneous co-formulation consisting of HER2...

XPENG-Peking University Collaborative Research Accepted by AAAI 2026: Introducing a Novel Visual Token Pruning Framework for Autonomous Driving

XPENG-Peking University Collaborative Research Accepted by AAAI 2026: Introducing a Novel Visual Token Pruning Framework for Autonomous Driving

XPENG-PKU Research Breakthrough: XPENG, in collaboration with Peking University, has developed FastDriveVLA—a novel visual token pruning framework that enables autonomous driving AI to "drive like a human" by focusing only on essential information,...

Co-PSMA abstract accepted for oral presentation at EAU Annual Congress 2026

Co-PSMA abstract accepted for oral presentation at EAU Annual Congress 2026

SYDNEY, Dec. 24, 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...

Fosun International Honored with TVB's Highest Accolade, "Outstanding ESG Award"

Fosun International Honored with TVB's Highest Accolade, "Outstanding ESG Award"

HONG KONG, Dec. 22, 2025 /PRNewswire/ -- On 19 December 2025, the TVB ESG Awards 2025 Presentation Ceremony, hosted by Television Broadcasts Limited ("TVB"), was held at the Hong Kong Convention and Exhibition Center. Fosun International was honored...

NEW DRUG APPLICATION FOR TINENGOTINIB TABLETS ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION

NEW DRUG APPLICATION FOR TINENGOTINIB TABLETS ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION

NANJING, China and GAITHERSBURG, Md., Dec. 19, 2025 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the "TransThera") announced that the new drug application for Tinengotinib tablets has been accepted by the Center for Drug Evaluation ("CDE")of...

Alphamab Oncology Announces IND Application for Innovative PD-L1/ VEGFR2 Bispecific ADC JSKN027 was Officially Accepted by CDE

Alphamab Oncology Announces IND Application for Innovative PD-L1/ VEGFR2 Bispecific ADC JSKN027 was Officially Accepted by CDE

SUZHOU, China, Dec. 18, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that the Investigational New Drug (IND) application for JSKN027, an independently developed innovative bispecific antibody-drug conjugate (ADC) targeting...

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