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)…
All articles by Salong Debbarma
Salong Debbarma
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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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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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Corstasis Therapeutics partners CVL for Enbumyst integration
Corstasis Therapeutics has announced a collaboration with Cardiovascular Logistics (CVL) to advance the adoption and integration of Enbumyst nasal spray…
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UNICEF and Gavi to widen affordable malaria vaccine access
UNICEF and Gavi, the Global Alliance for Vaccines and Immunisation now known as the Vaccine Alliance, have announced a pricing…
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FDA grants accelerated approval for Otsuka’s IgAN therapy
Otsuka Pharmaceutical has secured accelerated approval from the US Food and Drug Administration (FDA) for Voyxact (sibeprenlimab-szsi) to reduce proteinuria…
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Made Scientific and Cellergy partner to advance CLG-001
Made Scientific and Cellergy Therapeutics have formed a manufacturing partnership to advance the latter’s CLG-001 mitochondrial therapy toward first-in-human studies.…
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Novartis secures approval from FDA for Itvisma to treat SMA
Novartis has received approval from the US Food and Drug Administration (FDA) for the Itvisma (onasemnogene abeparvovec-brve) gene replacement therapy…
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AstraZeneca to expand biomanufacturing in Maryland, US
AstraZeneca has announced a $2bn investment plan to expand its biomanufacturing presence in the US state of Maryland, aiming to…