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European Commission Approves DARZALEX as First Licensed Treatment for High-Risk Smouldering Multiple…

Jul 24, 2025
Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Commission has approved a new indication for DARZALEX (daratumumab) subcutaneous (SC)…
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Gefurulimab Shows Significant Improvement in Daily Function for gMG Patients in Phase III PREVAIL…

Jul 24, 2025
A new potential treatment for generalised myasthenia gravis (gMG), a rare and debilitating autoimmune neuromuscular disease, has shown promising results in a large international…
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Kling Bio and Sanofi Partner to Fast-Track Neutralizing Antibody Discovery

Jul 24, 2025
Biotech company Kling Bio has announced a new collaboration and license option agreement with global pharmaceutical giant Sanofi aimed at accelerating the discovery of neutralizing…
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Sutro Biopharma Partners with FDA to Advance Antibody Drug Conjugate Regulatory Standards

Jul 23, 2025
Sutro Biopharma, Inc., a company specializing in next-generation antibody drug conjugates (ADCs), has announced a new collaboration with the U.S. Food and Drug Administration (FDA) to…
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Sanofi to Acquire Vicebio, Boosting Respiratory Vaccine Portfolio

Jul 23, 2025
Sanofi has announced an agreement to acquire London-based biotechnology company Vicebio Ltd, expanding its presence in the respiratory vaccine space. The deal brings with it a promising…
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ProMIS Neurosciences Receives FDA Fast Track Designation for PMN310 Alzheimer’s Treatment

Jul 22, 2025
ProMIS Neurosciences announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead Alzheimer’s disease (AD) therapeutic candidate, PMN310.…
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AusperBio Secures China CDE Clearance to Launch Phase III Trial for AHB-137 in Chronic Hepatitis B

Jul 22, 2025
AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. have announced that China’s Center for Drug Evaluation (CDE) has approved their lead candidate, AHB-137, to proceed into a…
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Sarepta Therapeutics Announces Voluntary Pause of ELEVIDYS Shipments in the U.S.

Jul 22, 2025
Sarepta Therapeutics, a leader in precision genetic medicine for rare diseases, announced it has voluntarily and temporarily halted all shipments of ELEVIDYS (delandistrogene…
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J&J Seeks First FDA Approval for Icotrokinra to Treat Plaque Psoriasis

Jul 22, 2025
Johnson & Johnson has officially submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for icotrokinra, an investigational first-in-class…
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AstraZeneca to Invest $50 Billion in U.S. for Drug Manufacturing and R&D

Jul 22, 2025
AstraZeneca announces $50 billion of investment in the United States by 2030, building on America’s global leadership in medicines manufacturing and R&D. This investment is expected…
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