エンハーツ、HER2陽性早期乳がんの術後療法で米国FDAの優先審査に指定 再発・死亡リスクを53％低減 | STELLANEWS.LIFE STELLANEWS.LIFE（ステラニュース・ライフ）は、科学や技術、医薬品分野における最新の研究成果や発見 | STELLANEWS.LIFE（ステラニュース・ライフ）は、科学や技術、医薬品分野における最新の研究成果や発見

【ENHERTU Granted Priority Review in the US for Patients with HER2-Positive Early Breast Cancer】
エンハーツ、HER2陽性早期乳がんの術後療法で米国FDAの優先審査に指定 再発・死亡リスクを53％低減

stellanews.life/technology/9...

#Enhertu #BreastCancer #FDA #PriorityReview #HER2Positive #MedicalNews

ファイザー、HYMPAVZIのsBLAがFDAに受理 優先審査付与で小児・インヒビター保有血友病へ適応拡大目指す | STELLANEWS.LIFE STELLANEWS.LIFE（ステラニュース・ライフ）は、科学技術・医療・ライフサイエンスの分野における研究 | STELLANEWS.LIFE（ステラニュース・ライフ）は、科学技術・医療・ライフサイエンスの分野における研究

U.S. FDA Accepts Pfizer’s Supplemental Biologics License Application for Priority Review of HYMPAVZI (marstacimab)

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#Hemophilia #Pfizer #FDA #HYMPAVZI #PriorityReview #ClinicalTrials

第一三共、Dato-DXdのTNBC一次治療でFDA優先審査──TROPION-Breast02に基づく生物学的製剤一部変更承認申請が受理 | STELLANEWS.LIFE STELLANEWS.LIFE（ステラニュース・ライフ）は、科学や技術、医薬品分野における最新の研究成果や発見 | STELLANEWS.LIFE（ステラニュース・ライフ）は、科学や技術、医薬品分野における最新の研究成果や発見

第一三共、Dato-DXdのTNBC一次治療でFDA優先審査──TROPION-Breast02に基づく生物学的製剤一部変更承認申請が受理
FDA grants Priority Review for datopotamab deruxtecan in first-line TNBC based on TROPION-Breast02

stellanews.life/technology/8...

#TNBC #BreastCancer #DatoDXd #TROP2 #FDA #PriorityReview

NeurologyLive - Clinical Neurology News and Neurology Expert Insights NeurologyLive is your direct connection to the latest neurology news and interviews with expert neurologists in multimedia formats.

🚨 FDA Update in #Narcolepsy

The #FDA has accepted Takeda’s NDA for oveporexton (TAK-861), an oral orexin receptor 2 agonist for narcolepsy type 1 — and granted Priority Review.

🗓️ PDUFA date: Q3 2026

Read more: www.neurologylive.com/view/fda-acc...
#PriorityReview #SleepMedicine #Neurology #NT1

Otsuka preps for July decision on centanafadine for ADHD The FDA has started a priority review of Otsuka's triple-acting drug for ADHD, setting up a decision on the first-in-class drug in July.

The #FDA has started a #priorityreview of #OtsukaPharma's triple-acting drug for attention-deficit hyperactivity disorder (#ADHD), centanafadine, setting up a decision by 24th July.

FDA starts priority review of BeOne's Venclexta rival BeOne nears a possible FDA okay for sonrotoclax in mantle cell lymphoma, hoping to be the second BCL-2 inhibitor in the US after AbbVie's Venclexta.

The #FDA has started a #priorityreview of #BeOne Medicines' BCL2 inhibitor sonrotoclax in relapsed or refractory mantle cell #lymphoma (MCL), setting up a decision on US approval next year.

pharmaphorum.com/news/fda-sta...

FDA Accepts Priority Review of BLA for Orca-T in Hematologic Malignancies The FDA accepted Priority Review of the BLA for Orca-T in several hematological malignancies, including acute lymphoblastic leukemia (ALL).

Orca Bio announced that the @fda.gov has accepted for Priority Review the Biologics License Application for Orca-T, an allogeneic T-cell immunotherapy to treat #HematologicCancers, including #ALL, #MDS, and #AML.

Learn more: https://bit.ly/3IN9jmx

#RareDisease #PriorityReview #OrcaT #Oncology

FDA Grants Priority Review to Liso-Cel for R/R Marginal Zone Lymphoma The FDA granted priority review to a supplemental biologics license application for lisocabtagene maraleucel in relapsed/refractory marginal zone lymphoma.

FDA Grants Priority Review to Liso-Cel for R/R Marginal Zone Lymphoma
@fda.gov #MZL #PriorityReview
www.onclive.com/view/fda-gra...

Click Subscribe #AscendisPharma #StockMarket #FDA #PriorityReview #PharmaNews

Question: before we give #PriorityReview vouchers for #Ebola, is there evidence that they're effective incentives? blogs.wsj.com/pharmalot/2014/10/29/law...