News and Press Releases
PADCEVTM (enfortumab vedotin) in Combination with Keytruda (pembrolizumab) Receives Positive CHMP Opinion for the Treatment of Patients with Resectable Muscle-Invasive Bladder Cancer who are Ineligible for Cisplatin-Based Chemotherapy
Positive opinion is based on data from the pivotal Phase 3 EV-303 trial showing a 60% reduction in the risk of disease recurrence, progression or death and a 50% reduction...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 22, 2026
Chiesi Receives MHRA Approval for Additional Dosing Regimen of Elfabrio (pegunigalsidase alfa) 2mg/kg administered every-four-weeks in adults stable with an enzyme replacement therapy
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved an additional dosing regimen of 2mg/kg administered every-four-weeks for pegunigalsidase alfa in adults stable with an enzyme replacement therapy...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 14, 2026
EMA Approves Updated Safety Information for Kite’s YESCARTA and TECARTUS Allow for a More Flexible Post-Infusion Management Approach
Update Enhances Convenience and Flexibility for Healthcare Professionals and Eligible Patients, while Maintaining CAR-T Safety Management Standards 24 April 2026 -- Stockley Park, UK -- Gilead and Kite Oncology today announced...
Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: April 24, 2026
Johnson & Johnson’s DARZALEX (daratumumab) becomes the first oncology injectable approved for administration by patients or caregivers
Landmark decision by CHMP grants approval for self or caregiver administration for patients living with multiple myeloma Milestone is a testament to ten years of daratumumab experience and innovation, continuing...
Category: Biotechnology, Clinical Trials, Drug Delivery, Drug Discovery, Pharmaceutical
Posted: March 27, 2026
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SteinCares and Shilpa Biologicals Strike into Licensing Agreement to Expand Access to Biosimilars Across Latin America
New partnership combines Shilpa Biologicals’ development and manufacturing capabilities with SteinCares’ regional commercialization platform Collaboration aims to expand patient access to cost-effective treatments and reinforces SteinCares’ leadership in biosimilars across...
Category: Biotechnology, Manufacturing and Packing, Other
Posted: March 10, 2026
STADA and Bio-Thera receive European Marketing Authorization for Gotenfia, a Biosimilar to Simponi
European Commission grants approval for Gotenfia, a golimumab biosimilar to Simponi that was developed by Bio-Thera and will be marketed by STADA Launch preparations are underway to bring the second...
Category: BioManufacturing, Drug Discovery, Manufacturing and Packing, Other, Pharmaceutical
Posted: February 13, 2026
Johnson & Johnson receives CHMP positive opinion for AKEEGA (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations
AMPLITUDE is the first clinical trial to evaluate potential therapies for patients with mHSPC and known HRR gene alterations, with positive results supporting the niraparib-based combination regimen as a new standard...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 30, 2026
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
ALK receives positive CHMP opinion for EURneffy 1mg (nasal adrenaline spray) for emergency anaphylaxis treatment in children (≥15kg)
30 January 2026 -- Hørsholm – Denmark -- Today ALK announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a...
Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: January 30, 2026
Samsung Bioepis Reaches Settlement Agreement for Eylea (Aflibercept) Biosimilar in Europe and the Rest of the World
30 January 2026 -- Incheon, Korea -- Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Regeneron and Bayer concerning the commercialization of SB15, a biosimilar to...
Category: Drug Discovery, Other, Pharmaceutical
Posted: January 30, 2026
Samsung Epis Holdings Delivers Business Updates at the 44th J.P. Morgan Healthcare Conference
Samsung Bioepis plans to secure 20 biosimilars in its products and pipeline by 2030 The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab, in addition to...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 15, 2026
Samsung Bioepis Begins Commercialization of BYOOVIZ, Biosimilar to Lucentis (Ranibizumab), in Europe
Samsung Bioepis completes full transfer of commercial rights from Biogen back to Samsung Bioepis for BYOOVIZ BYOOVIZ becomes the fourth biosimilar directly commercialized by Samsung Bioepis in Europe, following EPYSQLI...
Category: Logistics, Other, Pharmaceutical
Posted: January 2, 2026
Horus Pharma announces strategic Agreement to commercialize Formycon’s Aflibercept Biosimilar FYB203 under the brand name Baiama across Key European Markets including its Home Market France
23 October 2025 -- Nice, France -- Horus Pharma, the second largest independent ophthalmological laboratory in France and a leading player in Europe, today announced that it has entered into...
Category: Logistics, Other, Pharmaceutical
Posted: October 23, 2025
SOM Biotech secures clear registrational path for SOM3355 in Huntington’s disease after FDA End‑of‑Phase 2 Meeting
20 October 2025 -- Barcelona, Spain -- SOM Biotech, a clinical-stage company dedicated to the discovery and development of innovative therapies for rare central nervous system disorders, announces today that it...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 20, 2025
IAVI, Minapharm, and ProBioGen Announce Memorandum of Understanding to Progress Clinical Development, Manufacturing, Commercialization, and Access to Vaccines and Antibodies in Africa
Partners will advance end-to-end development of biologics for regionally prioritized diseases starting with Mpox and HIV 10 October 2025 -- Cairo, Egypt; Berlin, Germany; and New York, New York -- IAVI,...
Category: Biotechnology, Drug Delivery, Logistics, Manufacturing and Packing, Other, Pharmaceutical
Posted: October 10, 2025
Hikma and Celltrion strengthen partnership to expand biosimilar access in MENA
6 October 2025 -- London, UK -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, and its long-standing partner Celltrion Inc., a global biopharmaceutical leader, have signed exclusive licensing agreements...
Category: Logistics, Other, Pharmaceutical
Posted: October 6, 2025
