GE HealthCare’s PET imaging agent gains Alzheimer’s label expansion
The US Food and Drug Administration (FDA) has expanded the indications of an imaging agent developed by GE HealthCare, which …
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Medera and Novoheart collaborate on mini-heart models for HLHS
Medera and its subsidiary Novoheart have collaborated with scientists at the University of California San Diego School of Medicine and …
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Alzheimer’s R&D resurgence driven by $16.8bn in acquisitions in 2025YTD
Biopharmaceutical companies developing Alzheimer’s disease innovator drugs have witnessed a flurry of acquisitions over the past few years, surging in …
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Revolution Medicines partners Royalty Pharma on $2bn funding
Revolution Medicines has partnered Royalty Pharma for $2bn in flexible funding to support the independent worldwide development and commercialisation strategy …
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FDA approves Sanofi and Regeneron’s Dupixent for bullous pemphigoid
The US Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s Dupixent (dupilumab) as a treatment option for adults …
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Pharmaceutical Technology Excellence Awards 2025: i3 Membrane
ii3 Membrane has won three awards in the Innovation, Research and Development (R&D), and Environmental categories in the 2025 Pharmaceutical …
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Overcoming technical challenges in gene therapy product fill-finish operations
Gene therapy holds transformative potential in treating a wide range of diseases—from cancer and genetic disorders to infectious diseases. While …
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Zambon gains Chinese regulatory authority approval for Fluimucil IV
Zambon Pharma has received approval from Chinese regulatory authorities and launched Fluimucil (N-acetylcysteine) intravenous (IV) formulation in the country. The development …
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Navamedic signs agreement to acquire dne pharma
Navamedic has signed an agreement for the acquisition of Norwegian company dne pharma in a Nkr225m ($22m) deal. This acquisition marks …
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Hims & Hers shares plummet 35% as Novo Nordisk pulls partnership plug
Novo Nordisk has terminated a collaboration agreement with Hims & Hers, accusing the telehealth company of "failing to adhere to …
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FDA genAI reviews hinge on clarity of dossiers
Sponsors will need to ensure they are complying and submitting full, understandable dossiers if they are hoping to benefit from …
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FDA approves AstraZeneca and Daiichi Sankyo’s Datroway for NSCLC
The US Food and Drug Administration (FDA) has approved AstraZeneca and Daiichi Sankyo's Datroway (Datopotamab deruxtecan) for adults with locally …
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Bayer’s Eylea market grip set to slip as Alvotech biosimilar closes in
Alvotech has moved one step closer to entering the Eylea (aflibercept 2 mg) biosimilar market, after a European Medicines Agency …
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Harbour BioMed partners Otsuka on new T-cell therapy
Harbour BioMed has entered a strategic partnership with Otsuka Pharmaceutical focusing on the development of HBM7020, a B-cell maturation antigen …
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Bridging the gap: A comprehensive approach to social determinants of health
As the focus on personalized, equitable healthcare continues to intensify, social determinants of health (SDoH) have attracted significant attention in …
