Celltrion's YUFLYMA Achieves FDA Interchangeable Status
YUFLYMA is an FDA-approved, high-concentration (100mg/mL) and citrate-free formulation of Humira® biosimilar, approved for multiple inflammatory indications.
Global Pharma | 15/04/2025 | By Abha | 452
SMPA and NCI Collaborate to Expand Potential of Enzomenib in Precision Oncology
Enzomenib is an investigational, oral, small-molecule currently being clinically evaluated by SMPA in Phase 1/2 clinical trials for relapsed or refractory acute leukemia.
Global Pharma | 15/04/2025 | By Abha | 358
CytoSorbents Appoints Thomas Shannon as VP of Marketing for North America
CytoSorbents Corporation announced the appointment of Thomas Shannon as Vice President of Marketing for North America. With anticipated marketing approval, Shannon will lead the marketing strategy and execution for DrugSorb™-ATR in the US and Canada.
Global Pharma | 14/04/2025 | By Manvi | 533
J&J MedTech Completes First Clinical Cases with OTTAVA Robotic Surgical System
Johnson & Johnson MedTech announced completion of the first cases in the clinical trial for the OTTAVA™ Robotic Surgical System. The cases mark the first clinical experience with the OTTAVA System.
Global Pharma | 14/04/2025 | By Manvi | 387
Aurobindo Pharma Secures Final Approval for Rivaroxaban Tablets USP, 2.5mg
Aurobindo Pharma has received final USFDA approval to manufacture and market Rivaroxaban Tablets USP, 2.5 mg, the generic equivalent of XARELTO (2.5 mg). The company plans to launch it in Q1 FY26. It also received tentative approval for 10 mg, 15 mg, and 20 mg strengths.
Global Pharma | 14/04/2025 | By Manvi | 345
Zydus Secures Final Approval from USFDA for Jaythari (Deflazacort) Tablets in Multiple Dosages
Zydus Lifesciences Ltd. has received final USFDA approval to manufacture Jaythari (Deflazacort) Tablets in multiple strengths, a generic version of Emflaza, for the treatment of Duchenne muscular dystrophy.
Global Pharma | 14/04/2025 | By Manvi | 220
Amgen Reports Positive Interim Results for IMDELLTRA in Small Cell Lung Cancer Study
IMDELLTRA demonstrated statistically significant and clinically meaningful improvement in overall survival compared to local standard-of-care chemotherapy.
Global Pharma | 14/04/2025 | By Abha | 520
Taiwan MOHW Approves ACRO Biomedical's ABCcolla Collagen Ophthalmic Matrix
According to WHO, over 20 million people suffer from blindness due to corneal injuries or infections, yet only around 100,000 corneal transplants are performed annually, leading to a severe shortage.
Global Pharma | 14/04/2025 | By Abha | 317
Turbett Surgical Receives FDA 510(k) Clearance for Enhanced Instrument Pod Portfolio
Turbett Surgical's Instrument Pods receive FDA 510(k) clearance, boasting increased weight capacity of up to 300 lbs for the TS1200 and expanded lumen validation for improved surgical instrument management.
Global Pharma | 11/04/2025 | By Manvi | 561
Intrinsic Therapeutics Appoints Keith Valentine as President and Chief Executive Officer
Intrinsic Therapeutics, announced the appointment of Keith Valentine as President and Chief Executive Officer. Valentine will also join the Board of Directors and will begin his role in early May.
Global Pharma | 11/04/2025 | By Manvi | 304
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