“Sharp” funding cuts disrupt PrEP access to millions of HIV patients
The World Health Organization (WHO) has called for access expansion to newly approved human immunodeficiency virus (HIV) medication amid “sharp …
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Eisai seeks PMDA approval for subcutaneous Leqembi in Japan
Eisai has submitted a new drug application seeking approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for Leqembi’s (lecanemab) subcutaneous (SC) …
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Potentially “groundbreaking” FDA gene therapy pathway leaves key issues unresolved
The US Food and Drug Administration’s (FDA’s) new pathway for gene therapies could be “groundbreaking” if applied broadly, though the …
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US FDA approves Lupin’s Armlupeg injection
Lupin has received US Food and Drug Administration (FDA) approval for Armlupeg (pegfilgrastim-unne) 6mg/0.6ml injection in a single-dose prefilled syringe …
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Pharmaceutical Technology Excellence Awards 2025: West Pharmaceutical Services
West Pharmaceutical Services has long been a reference point in primary packaging for injectable therapies. Its latest launch—the West Synchrony™ …
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Pharmaceutical Technology Excellence Awards 2025: West Pharmaceutical Services
West Pharmaceutical Services has long been a reference point in primary packaging for injectable therapies. Its latest launch—the West Synchrony™ …
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WHO warns of immunisation strategy gaps amid measles outbreaks
The World Health Organisation (WHO) has reported a sharp drop in deaths from measles in recent decades yet warned that …
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Celltrion secures Health Canada go-ahead for Eylea biosimilar
South Korean biopharma Celltrion has obtained regulatory approval for its Eylea (aflibercept) biosimilar, Eydenzelt, from Health Canada. The therapy will now …
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Podcast: What key trends are people talking about in pharma?
As the last leaves of Autumn fall, the healthcare conference scene ramps up its activity before the end of the …
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Over half of European HIV patients diagnosed late, ECDC report finds
A European 2025 HIV/AIDS surveillance report has revealed that countries within the continent are currently failing to test and treat …
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IASO Bio gains Hong Kong approval for Fucaso application
IASO Biotechnology has received the Hong Kong Department of Health's approval for its biologics licence application (BLA) for the fully …
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MHRA approves Roche’s inavolisib for breast cancer
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval to Roche's Itovebi (inavolisib) to treat adults with …
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Valneva trims R&D footprint by shutting French facility
Not long after cutting its sales forecast for 2025, Valneva has decided to decrease its operational footprint in France by …
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SK bolsters oncology pipeline in radiopharmaceutical licensing deal
SK Biopharmaceuticals has in-licensed its second radiopharmaceutical – this time from a US-based academic organisation – in a bid to …
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BeOne’s sonrotoclax gains priority FDA review for mantle cell lymphoma
The US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for BeOne Medicines’ B-cell lymphoma 2 …
