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FDA Expands Approval of Lilly’s Jaypirca for Earlier CLL/SLL Treatment

Dec 4, 2025
Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has granted expanded approval for Jaypirca (pirtobrutinib) for adults with relapsed or refractory…
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Formosa Pharmaceuticals Grants Rxilient Rights to New Ophthalmic Drug

Dec 4, 2025
Taiwan-based Formosa Pharmaceuticals (6838.TW) has entered into an exclusive licensing agreement with Singapore-headquartered Rxilient Medical Pte. Ltd., granting the company…
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AGC Biologics Expands Cell Line Center With ATUM Partnership

Dec 4, 2025
Global biopharmaceutical contract development and manufacturing organization (CDMO) AGC Biologics has announced a major expansion of its Cell Line Development Center of Excellence…
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FDA Names Tracy Beth Høeg as Acting Director of Drug Evaluation Center

Dec 4, 2025
The U.S. Food and Drug Administration (FDA) has appointed Tracy Beth Høeg, M.D., Ph.D., as the acting director of the Center for Drug Evaluation and Research (CDER), marking a…
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FDA Proposes New Guidance to Reduce Non-Human Primate Testing

Dec 3, 2025
The U.S. Food and Drug Administration (FDA) has issued new draft guidance identifying specific drug product types for which six-month non-human primate (NHP) toxicity studies can be…
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Citizen Health and UCB Launch AI-Driven Partnership for Rare Diseases

Dec 3, 2025
Citizen Health has announced a major strategic partnership with UCB, a global biopharmaceutical leader in neurological and autoimmune research, to accelerate drug discovery and…
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IQVIA Partners with AWS to Advance Agentic AI in Life Sciences

Dec 2, 2025
IQVIA has announced a major strategic collaboration with Amazon Web Services (AWS), naming the cloud company as its Preferred Agentic Cloud Provider—a move set to accelerate the digital…
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FDA Grants Breakthrough Status to Ionis’ Olezarsen for sHTG

Dec 2, 2025
Ionis Pharmaceuticals has announced a major regulatory milestone for its investigational therapy olezarsen, as the U.S. Food and Drug Administration (FDA) has granted it Breakthrough…
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Lupin Wins FDA Approval for Armlupeg Pegfilgrastim Biosimilar

Dec 2, 2025
Lupin Limited has secured a key regulatory milestone with the U.S. Food and Drug Administration granting approval to Armlupeg™ (pegfilgrastim-unne), the company’s first biosimilar to…
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Regeneron, Tessera Partner on Gene Writing Therapy for AATD

Dec 2, 2025
Regeneron Pharmaceuticals and Tessera Therapeutics have entered into a major global collaboration to advance TSRA-196, an investigational in vivo Gene Writing therapy designed to…
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Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry.

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Press Releases

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