BioPharma Drug Approval
Kelun Biotech And Crescent Biopharma Forge Global Partnership To Advance Next Generation Oncology Therapies
Companies to advance CR-001, a PD-1 x VEGF bispecific antibody, and SKB105, an integrin beta-6-directed antibody-drug conjugate (ADC), in global markets an...
December 05, 2025 | News
Formosa Pharmaceuticals Grants Exclusive ASEAN Rights For APP13007 To Rxilient Medical
Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TW) announced that the company has entered into an exclusive licensing agreement with Rxil...
December 04, 2025 | News
Antengene Secures Expanded Approvals For Xpovio In Hong Kong Across Multiple Myeloma And DLBCL
- XPOVIO® (selinexor) has received approvals for three indications in Hong Kong. These include its previous approval as the treatment for mul...
December 04, 2025 | News
Samsung Bioepis Gains CHMP Backing for BYOOVIZ Pre Filled Syringe
European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopts positive opinion for BYOOVIZ® (ranibizuma...
December 03, 2025 | News
Ascletis Advances First Oral Triple Agonist for Obesity, ASC37, into Clinical Development
- Utilizing Ascletis' Peptide Oral Transport ENhancement Technology (POTENT), ASC37 oral tablets achieved average absolute oral bioavailability ...
December 01, 2025 | News
IASO Bio Achieves Landmark Hong Kong Approval for Fucaso CAR-T Therapy
IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company dedicated to the discovery, development, manufacturing, and commerciali...
November 28, 2025 | Regulatory
Zydus and RK Pharma Partner on Innovative Sterile Injectable for Oncology Supportive Care
Zydus Lifesciences Ltd. (including its subsidiaries and affiliates), a global innovation-driven healthcare company, announced that it has entered into an e...
November 27, 2025 | News
Accord BioPharma Gains FDA Approval for Two Denosumab Biosimilars to Expand Access to Osteoporosis and Cancer Related Bone Care
Products will treat osteoporosis and skeletal-related events from certain types of bone cancer, expanding the company's biosimilar portfolio Accord BioPha...
November 21, 2025 | News
Vaxcellbio’s CSO Outlines How DDS Enabled Nanobodies Could Redefine Global Treatment Pathways
Vaxcellbio is betting on the combined power of nanobodies and advanced drug delivery science to push boundaries across ophthalmology and other chronic dise...
November 20, 2025 | Interaction
AbbVie Secures Approval for EPKINLY in Combination With R2 as the First Bispecific Therapy for Relapsed or Refractory Follicular Lymphoma
EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) is now the first and only bispecific antibody combination therapy available f...
November 19, 2025 | News
Shanghai Henlius and Organon Achieve FDA Approval for POHERDY, First Pertuzumab Biosimilar in the US
Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has approved the Biologics...
November 19, 2025 | News
Lundbeck Moves Closer to Asian Launch of Vyepti with New Drug Application Accepted in Japan
Lundbeck's new drug application (NDA) for Vyepti® (eptinezumab) accepted by Japan's Ministry of Health, Labor and Welfare (MHLW), mark...
November 17, 2025 | News
Lupin Launches Risperidone Long Acting Injectable in the United States with PrecisionSphere Technology
Global pharma major Lupin announced the launch of Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 5...
November 17, 2025 | News
EirGenix and Sandoz Sign USD 152 Million Global Deal for Pertuzumab Biosimilar
EirGenix Inc. announced that it has entered into a second global exclusive licensing agreement with international biosimilar leader Sandoz AG (SIX:SDZ/OTCQ...
November 13, 2025 | News
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