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FDA Grants Priority Review for WINREVAIR Label Update Following ZENITH Trial Results

Jul 3, 2025
Merck, known as MSD outside the U.S. and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to a supplemental Biologics License…
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FDA Grants Accelerated Approval to ZEGFROVY, First Oral EGFR‑Exon‑20 Insertion NSCLC Therapy

Jul 3, 2025
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to ZEGFROVY (sunvozertinib), a novel oral therapy developed by Dizal, for the treatment of adults with…
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Adagene Secures Up to $25M Strategic Investment from Sanofi

Jul 3, 2025
Adagene Inc., a biotechnology company developing innovative antibody-based cancer therapies, announced that Sanofi will invest up to $25 million in the company as part of an expanded…
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Lynozyfic (linvoseltamab-gcpt) Granted FDA Accelerated Approval for Relapsed/Refractory Multiple…

Jul 3, 2025
Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic (linvoseltamab-gcpt) to treat adult patients…
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Riliprubart Earns Orphan Drug Designation in Japan for CIDP

Jul 2, 2025
The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation to riliprubart, an investigational monoclonal antibody developed by Sanofi, for the…
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FDA Approves Gamifant as First Treatment for MAS in Still’s Disease

Jul 1, 2025
Sobi announced that the U.S. Food and Drug Administration (FDA) approved Gamifant (emapalumab-lzsg) for the treatment of adult and pediatric (newborn and older) patients with…
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FDA Eases Monitoring Rules, Removes REMS from BMS Cell Therapies

Jul 1, 2025
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved label updates for both of its CAR T cell therapies, Breyanzi (lisocabtagene maraleucel;…
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Vetter Breaks Ground on New Clinical Site

Jul 1, 2025
Vetter, a leading, globally operating Contract Development and Manufacturing Organization (CDMO), celebrated the start of construction for its new clinical manufacturing site in Des…
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Piramal Pharma Solutions Breaks Ground on $90M Expansion

Jul 1, 2025
Piramal Pharma Solutions, a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd., recently announced a $90M investment plan to…
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AbbVie to Acquire Capstan Therapeutics, Advancing Immunology Innovation

Jul 1, 2025
AbbVie and Capstan Therapeutics, Inc. announced a definitive agreement under which AbbVie will acquire Capstan, including CPTX2309, a potential first-in-class in vivo tLNP anti-CD19…
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