FDA grants ODD status to Zai Lab’s lung cancer treatment
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Zai Lab’s delta-like ligand 3 (DLL3)…
Oncology
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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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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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CDE grants BTD to Innovent’s IBI343 for pancreatic cancer
The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted breakthrough therapy designation (BTD) to…
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Light Horse emerges with $62m and Novartis partnership worth up to $1bn
Light Horse Therapeutics has galloped on to the biotech scene with $62m in Series A financing and a multi-target collaboration…
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Samsung Biologics and LigaChem extend ADC services deal
Samsung Biologics has extended its collaboration with LigaChem Biosciences for antibody-drug conjugate (ADC) services. The partnership will leverage Samsung Biologics'…
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Chugai and Araris enter $780m ADC research collaboration
Chugai Pharmaceutical and Araris Biotech have entered an antibody-drug conjugate (ADC)-focused research collaboration and option-to-license agreement worth up to $780m.…
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EMA gives OMPD to Actuate’s pancreatic cancer therapy
Actuate Therapeutics has gained orphan medicinal product designation (OMPD) from the European Medicines Agency (EMA) for elraglusib to treat pancreatic…
