Pharma Journalist -

The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of Daiichi Sankyo and…
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AbbVie announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa)…
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Carisma Therapeutics Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced that the U.S. Food and Drug…
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Eli Lilly and Company announced a collaboration with OpenAI that will allow Lilly to leverage OpenAI's generative AI to invent novel antimicrobials to treat drug-resistant pathogens.…
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AstraZeneca’s Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy has been approved in Japan for the 1st-line treatment of adult patients with locally…
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GSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Omjjara (momelotinib) for the treatment of myelofibrosis. Omjjara is a once-a-day, oral…
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Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced positive topline results from its HELIOS-B Phase 3 study of vutrisiran, an investigational RNAi…
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AstraZeneca’s Imfinzi (durvalumab) in combination with carboplatin and paclitaxel followed by Imfinzi monotherapy has been approved in the US as treatment for adult patients with…
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Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a fixed combination of amivantamab and…
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Charles River Laboratories International, Inc. and Captain T Cell, a spinoff from the renowned Max Delbrück Center Berlin, Germany,  announced a plasmid DNA and retrovirus vector…
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