Pfizer’s colorectal cancer combo therapy gains accelerated approval from FDA
Pfizer has gained accelerated approval from the US Food and Drug Administration (FDA) for BRAFTOVI (encorafenib) in conjunction with cetuximab…
Oncology
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China NMPA approves MSD’s KEYTRUDA for stages of NSCLC
China National Medical Products Administration (NMPA) has approved MSD’s KEYTRUDA for use in conjunction with platinum-containing chemotherapy as a neoadjuvant…
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GSK’s lung cancer therapy gains EMA PRIME designation
GlaxoSmithKline (GSK)’s B7-H3-targeted antibody-drug conjugate (ADC), GSK’227 has gained priority medicines (PRIME) designation from the European Medicines Agency (EMA) for…
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ASH 2024: Regeneron’s Ordspono faces challenges, but positive results signal hope
Data from the Phase II ELM-2 trial was presented at the American Society of Hematology (ASH) 2024 Annual Meeting, held…
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Priority FDA review given to AstraZeneca’s Imfinzi sBLA for MIBC
The US Food and Drug Administration (FDA) has granted priority review to AstraZeneca's supplemental biologics licence application (sBLA) for Imfinzi (durvalumab),…
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FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy
The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to Affimed and Artiva Biotherapeutics’…
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Dewpoint Therapeutics and Mitsubishi Tanabe link on ALS treatment
Dewpoint Therapeutics and Mitsubishi Tanabe Pharma Corporation (MTPC) have entered a strategic research partnership focusing on the development of the…
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FDA approves AstraZeneca’s Imfinzi to treat LS-SCLC
The US Food and Drug Administration (FDA) has approved AstraZeneca's human monoclonal antibody, Imfinzi (durvalumab), to treat limited-stage small cell…
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Ipsen and Biomunex enter agreement for cancer therapy
Ipsen has entered an exclusive worldwide licensing agreement with Biomunex Pharmaceuticals for BMX-502, a first-in-class bispecific antibody designed to engage…
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Takeda licensed for anaemia therapy by Keros Therapeutics
Takeda has agreed to receive an exclusive global licence from Keros Therapeutics to advance the development, manufacture and commercialisation of…
