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Henlius Secures U.S. FDA Orphan Drug Designation for HLX22 in Gastric Cancer Treatment
Thursday, March 20, 2025Shanghai Henlius Biotech has received Orphan Drug Designation ODD from the US Food and Drug Administration FDA for HLX an innovative antiHER monoclonal antibody mAb intended for the treatment of gastric cancer
Alvotech and Dr. Reddy’s Announce FDA Acceptance of BLA for AVT03, a Biosimilar for Osteoporosis and Bone Disease
Wednesday, March 19, 2025Dr Reddys Laboratories and Alvotech have announced that the US Food and Drug Administration FDA has accepted the Biologic Licence Application BLA for AVT a proposed biosimilar to Prolia denosumab and Xgeva denosumab
Vaxxas Secures U.S. Patent for Needle-Free Vaccine Manufacturing Technology
Wednesday, March 19, 2025Vaxxas has obtained a new patent from the United States Patent Office for its proprietary manufacturing technology The highdensity microarray patch HDMAP features thousands of tiny projections that carry a dried vaccine formulation When applied to th...
Alphamab Oncology’s Anti-HER2 Biparatopic ADC JSKN003 Receives Approval for Ovarian Cancer Treatment
Tuesday, March 18, 2025Alphamab Oncology and CSPC Pharmaceutical have announced that the antiHER biparatopic antibodydrug conjugate ADC JSKN has been granted Breakthrough Therapy Designation by the Centre for Drug Evaluation CDE of Chinas National Medical Products Administ...
Taiho Pharmaceutical to Acquire Araris Biotech in Oncology Expansion
Tuesday, March 18, 2025Taiho Pharmaceutical has announced the full acquisition of Araris Biotech The transaction follows a research collaboration between the two companies initiated in November
Akeso’s Penpulimab Approved for First-Line Nasopharyngeal Cancer Treatment
Monday, March 17, 2025Akeso has received approval from Chinas National Medical Products Administration NMPA for the use of its antiPD monoclonal antibody penpulimab as a firstline treatment for recurrent or metastatic nasopharyngeal cancer NPC in combination with chemothe...
Innovent Biologics Receives Approval of SYCUME® for Thyroid Eye Disease Treatment
Saturday, March 15, 2025Innovent Biologics has received approval from Chinas National Medical Products Administration NMPA for SYCUME teprotumumab N TED is a condition that affects around to of individuals with Graves disease and can also occur in those with other thyroid...
BioCity and MSD Collaborate on Clinical Trial for BC3195-KEYTRUDA® (Pembrolizumab) Cancer Treatment
Friday, March 14, 2025BioCity Biopharmaceutics has announced a clinical trial collaboration with MSD to assess the combination of BC and KEYTRUDA pembrolizumab in patients with locally advanced or metastatic solid tumours
Celltrion Launches STEQEYMA® (ustekinumab-stba) for Psoriasis and Inflammatory Diseases
Thursday, March 13, 2025Celltrion has announced the availability of STEQEYMA ustekinumabstba in the United States following its approval by the US Food and Drug Administration FDA in December Chronic inflammatory diseases such as psoriasis and psoriatic arthritis
Zai Lab’s Biologics Licence for TIVDAK Approved for Advanced Cervical Cancer Treatment
Thursday, March 13, 2025Zai Lab has announced that Chinas National Medical Products Administration NMPA has approved its Biologics Licence Application BLA for TIVDAK tisotumab vedotintftv for the treatment of patients with recurrent or metastatic cervical cancer who have ex...
