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FDA Grants Orphan Drug Status to Akeso’s Ligufalimab for AML

Sep 16, 2025
Akeso Inc. announced that its monoclonal antibody ligufalimab (AK117), targeting CD47, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration for the…
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Cadrenal Boosts Anticoagulation Pipeline with Acquisition of eXIthera’s Factor XIa Inhibitors

Sep 16, 2025
Cadrenal Therapeutics, Inc., a biopharmaceutical company focused on innovative anticoagulation therapies, has announced the acquisition of eXIthera Pharmaceuticals’ portfolio of Factor…
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aTyr Pharma Reports Positive Topline Results from Phase 3 Efzofitimod Sarcoidosis Trial

Sep 16, 2025
aTyr Pharma, Inc. a clinical-stage biotech company developing first-in-class therapeutics from its proprietary tRNA synthetase platform, today announced topline results from its Phase 3…
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EU Approves Novo Nordisk’s Oral Semaglutide as First GLP-1 Pill to Cut Heart Risks

Sep 16, 2025
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved an update to the label of Novo Nordisk’s oral diabetes drug Rybelsus (oral…
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FDA Approves Amneal’s Sodium Oxybate Oral Solution

Sep 15, 2025
Amneal Pharmaceuticals has received U.S. Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for sodium oxybate oral solution 500 mg/mL, a…
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LEAN Principles Take Center Stage at Upcoming LEAN Cell & Gene Therapy Summits in Boston and…

Sep 12, 2025
Boston, MA (September 22, 2025) & Washington, D.C. (November 6, 2025). The LEAN Cell & Gene Summit series, co-organised by ScaleReady, and Hanson Wade, is proud to unveil its…
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Sanofi’s SAR402663 Granted Fast Track Designation for Neovascular AMD in the US

Sep 12, 2025
The U.S. Food and Drug Administration (FDA) has granted fast track designation to Sanofi’s investigational gene therapy SAR402663 for treating neovascular age-related macular…
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Charles River Expands Oncology Manufacturing Through New Collaboration to Boost Cell and Gene…

Sep 12, 2025
Charles River Laboratories International, Inc. has announced two strategic partnerships aimed at advancing oncology research and accelerating the development of novel cancer therapies.…
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Zentiva Announces Sale from Advent to GTCR

Sep 12, 2025
Zentiva, a leading European generics pharmaceutical company, has been sold by Advent International to GTCR, two major global private equity firms announced today. Advent acquired…
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Tzield Approved in China as First Disease-Modifying Therapy for Stage 2 Type 1 Diabetes

Sep 12, 2025
The Chinese National Medical Products Administration (NMPA) has approved Tzield (teplizumab) as the country’s first disease-modifying therapy for autoimmune type 1 diabetes (T1D). The…
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Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry.

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Press Releases

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