FDA breakthrough status for Bluejay’s CHD therapy brelovitug
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Bluejay Therapeutics’ fully human immunoglobulin G1 (IgG1)…
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Catalent backs decentralised manufacture of Galapagos’ CAR-T therapy
Catalent has entered a strategic partnership with Galapagos to facilitate decentralised manufacturing in the US for the trials of the…
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Junshi partners LEO Pharma for toripalimab distribution in Europe
Shanghai Junshi Biosciences and its subsidiary TopAlliance Biosciences are set to enter a collaboration with LEO Pharma to distribute and…
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Health Canada gives Takeda’s mCRC capsules market authorisation
Health Canada has granted market authorisation to Takeda Canada for FRUZAQLA (fruquintinib) capsules to treat adults with metastatic colorectal cancer…
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EC approves GSK’s Jemperli-chemo combo for endometrial cancer
The European Commission (EC) has approved GSK's Jemperli (dostarlimab) combined with chemotherapy that includes carboplatin and paclitaxel for the first-line…
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HHS awards $590m to Moderna for mRNA ‘flu vax development
Moderna is set to receive $590m in funding from the US Department of Health and Human Services (HHS) to expedite…
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Feinstein Institutes gains NIH grant to explore ghrelin for GI-ARS
Northwell Health’s Feinstein Institutes for Medical Research has received a five-year, $2.9m grant from the National Institutes of Health (NIH)…
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FDA approves Amgen’s combo therapy for colorectal cancer
Amgen’s LUMAKRAS (sotorasib) and Vectibix (panitumumab) combination has received approval from the US Food and Drug Administration (FDA) to treat…
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IMPACT ovarian cancer capsules authorised in China
IMPACT Therapeutics has received the China National Medical Products Administration (NMPA) marketing authorisation for Senaparib capsules to treat ovarian cancer.…
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Charles River and Akron link to integrate cytokines into cell therapy
Charles River Laboratories and Akron Bio have announced the integration of the latter’s closed system solutions (CSS) liquid cytokines into…