美國食品藥物管理局

原文：U.S. Food and Drug Administration｜最近更新：2026-10-23

原文名稱
U.S. Food and Drug Administration
縮寫
FDA
類型
監管機構
國家
美國
主管領域／業務範圍
藥品、生物製劑與醫療器材審查核准

關鍵人物

海蒂．奧弗頓

相關政策

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相關藥品

Sarclisa Escena、Revtorpyk、mFLUSIVA、Tudriqev、Etcamah、Hyrnuo、Welireg、Lenvima、Tecentriq（含皮下劑型Tecentriq Hybreza）

涉及事件

FDA核准Sanofi Sarclisa Escena皮下注射劑型（多發性骨髓瘤）、FDA核准Celcuity Revtorpyk（gedatolisib）合併療法用於HR陽性HER2陰性乳癌、FDA核准Moderna首支mRNA流感疫苗mFLUSIVA、Replimune溶瘤病毒療法Tudriqev（RP1）併用Opdivo獲FDA加速核准治療晚期黑色素瘤、川普提名Heidi Overton出任美國FDA局長、AstraZeneca乳癌新藥camizestrant（Etcamah）獲歐盟核准一線適應症，美國FDA後續加速核准同一適應症；另一適應症試驗SERENA-4未達主要終點、FDA加速核准Bayer Hyrnuo（sevabertinib）擴大至第一線HER2突變非小細胞肺癌、FDA核准Merck belzutifan（Welireg）併用Eisai lenvatinib（Lenvima）治療晚期腎細胞癌、FDA核准Roche/Genentech Tecentriq（atezolizumab）併用化療用於第三期dMMR大腸癌輔助治療、FDA加速核准GSK Jemperli（dostarlimab）用於MSI-H/dMMR局部晚期直腸癌、GSK之Hibsago（bepirovirsen）獲美國FDA核准，為全球首款治療慢性B型肝炎之反義寡核苷酸藥物、AstraZeneca之Ultomiris（ravulizumab）獲美國FDA加速核准治療IgA腎病變

關聯關係

關係建立日期強度確定程度證據來源補充說明
核准 → FDA核准Sanofi Sarclisa Escena皮下注射劑型（多發性骨髓瘤）2026-07-09強確認FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indicationsFDA核准Sarclisa Escena皮下注射劑型
核准 → FDA核准Celcuity Revtorpyk（gedatolisib）合併療法用於HR陽性HER2陰性乳癌2026-07-14強確認FDA Approves Gedatolisib (Revtorpyk) With Fulvestrant, With or Without Palbociclib, for HR-Positive, HER2-Negative, Locally Advanced or Metastatic Breast CancerFDA核准Celcuity Revtorpyk（gedatolisib）
核准 → FDA核准Merck口服PCSK9抑制劑LIPFENDRA（enlicitide），為全球首款口服此類藥物2026-07-16強確認Merck's LIPFENDRA (enlicitide) is the First and Only Once-Daily Oral PCSK9 Inhibitor Approved by the U.S. FDA to Reduce LDL-C in Adults with HypercholesterolemiaFDA核准LIPFENDRA為全球首款口服PCSK9抑制劑
核准 → GSK之Jideytro（zidesamtinib）獲FDA核准治療ROS1陽性非小細胞肺癌2026-07-22強確認GSK secures first lung cancer approval as FDA clears Jideytro in quick payoff from Nuvalent dealFDA核准GSK之Jideytro（zidesamtinib）治療ROS1陽性非小細胞肺癌
監管 → 賽諾菲2026-07-22中確認FDA calls out Sanofi emails for giving 'misleading impression' of Beyfortus use in RSVFDA對Sanofi發出未具名警告函，指其Beyfortus專業郵件宣傳造成誤導印象
核准 → FDA核准Moderna首支mRNA流感疫苗mFLUSIVA2026-08-05強確認Moderna's mRNA flu shot mFlusiva snags FDA nod after refusal-to-file imbroglioFDA核准Moderna mFLUSIVA（mRNA流感疫苗）
核准 → Replimune溶瘤病毒療法Tudriqev（RP1）併用Opdivo獲FDA加速核准治療晚期黑色素瘤2026-08-06強確認Replimune secures FDA approval for melanoma therapy Tudriqev after long regulatory battleFDA加速核准Replimune Tudriqev（vusolimogene oderparepvec）併用Opdivo治療晚期黑色素瘤，第三次送審後獲核
監管 → FDA以生產製造疑慮駁回ITM放射性藥物177Lu-edotreotide（ITM-11）新藥申請2026-08-10強確認FDA rejects ITM's radiopharma drug over manufacturing problemsFDA以生產製造疑慮核發完整回覆函，駁回新藥申請
核准 → FDA加速核准BMS首個CELMoD藥物Zenbexus（iberdomide）併用daratumumab治療多發性骨髓瘤2026-08-13強確認FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myelomaFDA加速核准BMS之Zenbexus(iberdomide)治療多發性骨髓瘤
核准 → FDA核准Revolution Medicines daraxonrasib（Rasonque），全球首款用於胰臟癌之RAS抑制劑；歐盟CHMP建議跟進核准2026-08-26強確認FDA Approves Daraxonrasib for Metastatic Pancreatic AdenocarcinomaFDA核准daraxonrasib（Rasonque）用於轉移性胰臟腺癌，為全球首款用於此適應症之RAS抑制劑
核准 → Takeda／Protagonist之Mimrylo（rusfertide）獲美國FDA核准治療真性紅血球增多症2026-08-28強確認FDA Approves First Drug of Its Kind for Polycythemia Vera, a Rare Blood DisorderFDA核准Mimrylo（rusfertide）治療真性紅血球增多症
核准 → Eli Lilly之Mounjaro獲美國FDA新增降低第2型糖尿病心血管風險適應症2026-08-28強確認FDA approves Lilly's Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetesFDA核准Mounjaro新增降低心血管風險適應症
核准 → AstraZeneca乳癌新藥camizestrant（Etcamah）獲歐盟核准一線適應症，美國FDA後續加速核准同一適應症；另一適應症試驗SERENA-4未達主要終點2026-09-04強確認FDA Grants Accelerated Approval for New Breast Cancer Treatment (camizestrant/Etcamah)美國FDA對camizestrant（Etcamah）一線乳癌適應症核予加速核准
核准 → FDA加速核准Bayer Hyrnuo（sevabertinib）擴大至第一線HER2突變非小細胞肺癌2026-09-09強確認U.S. FDA Grants Accelerated Approval to Bayer's HYRNUO (sevabertinib) as a First-Line Targeted Therapy for Patients with HER2-Mutated Non-Small Cell Lung Cancer美國FDA核准Bayer Hyrnuo（sevabertinib）加速核准適應症擴大至第一線HER2突變NSCLC
核准 → FDA核准Merck belzutifan（Welireg）併用Eisai lenvatinib（Lenvima）治療晚期腎細胞癌2026-09-24強確認FDA approves belzutifan in combination with lenvatinib for advanced renal cell carcinoma核准belzutifan併用lenvatinib治療晚期腎細胞癌
核准 → FDA核准Roche/Genentech Tecentriq（atezolizumab）併用化療用於第三期dMMR大腸癌輔助治療2026-10-08強確認FDA Approves Atezolizumab in Combination with Chemotherapy for Stage III Mismatch Repair Deficient Colon CancerFDA核准Tecentriq併用化療用於第三期dMMR大腸癌輔助治療
核准 → FDA擴大核准ImmunityBio Anktiva用於僅乳突狀BCG治療無反應之非肌肉侵襲性膀胱癌2026-10-14強確認FDA clears ImmunityBio's Anktiva expansion in bladder cancer after regulatory whiplashFDA擴大核准ImmunityBio Anktiva用於僅乳突狀BCG治療無反應之NMIBC
核准 → FDA加速核准GSK Jemperli（dostarlimab）用於MSI-H/dMMR局部晚期直腸癌2026-10-19強確認Jemperli (dostarlimab-gxly) approved in US as first and only immunotherapy for adults with MSI-H/dMMR locally advanced rectal cancerFDA以12個月持續臨床完全反應為替代終點，加速核准Jemperli用於MSI-H/dMMR局部晚期直腸癌
核准 → GSK之Hibsago（bepirovirsen）獲美國FDA核准，為全球首款治療慢性B型肝炎之反義寡核苷酸藥物2026-10-20強確認Ionis partner GSK announces Hibsago (bepirovirsen) approved in the U.S. for the treatment of chronic hepatitis B (CHB)美國FDA核准GSK之Hibsago（bepirovirsen）上市
核准 → AstraZeneca之Ultomiris（ravulizumab）獲美國FDA加速核准治療IgA腎病變2026-10-21強確認AZ grabs FDA nod for Ultomiris in rare kidney disease IgANFDA加速核准AstraZeneca之Ultomiris（ravulizumab）用於IgA腎病變
核准 → FDA核准Pfizer Talzenna併用Xtandi用於HRR突變轉移性去勢敏感型攝護腺癌一線治療2026-10-26強確認FDA Approves Talazoparib Plus Enzalutamide for HRR-Mutated mHSPCFDA核准Talzenna併用Xtandi用於HRR突變mHSPC一線治療

更新紀錄

日期變更內容依據來源
2026-07-14首次建檔FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications
2026-07-15補充核准Celcuity Revtorpyk（gedatolisib）FDA Approves Gedatolisib (Revtorpyk) With Fulvestrant, With or Without Palbociclib, for HR-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
2026-08-06補充核准Moderna mFLUSIVA（mRNA流感疫苗）Moderna's mRNA flu shot mFlusiva snags FDA nod after refusal-to-file imbroglio
2026-08-07補充加速核准Replimune Tudriqev（RP1）併用Opdivo治療晚期黑色素瘤Replimune secures FDA approval for melanoma therapy Tudriqev after long regulatory battle
2026-08-20補充：川普提名Heidi Overton（海蒂．奧弗頓）出任局長，遞補5月辭職之Marty MakaryTrump set to nominate Heidi Overton to be FDA commissioner
2026-09-05補充：對AstraZeneca camizestrant（Etcamah）一線乳癌適應症核予加速核准，與諮詢委員會先前反對立場相反FDA Grants Accelerated Approval for New Breast Cancer Treatment (camizestrant/Etcamah)
2026-09-10補充：核准Bayer Hyrnuo（sevabertinib）加速核准適應症擴大至第一線HER2突變NSCLCU.S. FDA Grants Accelerated Approval to Bayer's HYRNUO (sevabertinib) as a First-Line Targeted Therapy for Patients with HER2-Mutated Non-Small Cell Lung Cancer
2026-09-26補充：核准belzutifan（Welireg）併用lenvatinib（Lenvima）治療晚期腎細胞癌FDA approves belzutifan in combination with lenvatinib for advanced renal cell carcinoma
2026-10-10補充：核准Genentech Tecentriq（atezolizumab）併用化療用於第三期dMMR大腸癌輔助治療FDA Approves Atezolizumab in Combination with Chemotherapy for Stage III Mismatch Repair Deficient Colon Cancer
2026-10-20補充：加速核准GSK Jemperli（dostarlimab）用於MSI-H/dMMR局部晚期直腸癌Jemperli (dostarlimab-gxly) approved in US as first and only immunotherapy for adults with MSI-H/dMMR locally advanced rectal cancer
2026-10-22新增關聯事件：核准GSK之Hibsago（bepirovirsen）用於治療慢性B型肝炎Ionis partner GSK announces Hibsago (bepirovirsen) approved in the U.S. for the treatment of chronic hepatitis B (CHB)

來源

標題發布日期來源機構分級可信度
FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications2026-07-09U.S. Food and Drug Administration第一級高
FDA Approves Gedatolisib (Revtorpyk) With Fulvestrant, With or Without Palbociclib, for HR-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer2026-07-14美國食品藥物管理局（FDA）第一級高
Moderna's mRNA flu shot mFlusiva snags FDA nod after refusal-to-file imbroglio2026-08-05FiercePharma第二級高
Replimune secures FDA approval for melanoma therapy Tudriqev after long regulatory battle2026-08-06FiercePharma第二級高
Trump set to nominate Heidi Overton to be FDA commissioner2026-08-18STAT News第二級高（已與Washington Post、CNN、ABC News、The Hill等多方報導交叉驗證）
FDA Grants Accelerated Approval for New Breast Cancer Treatment (camizestrant/Etcamah)2026-09-04U.S. Food and Drug Administration第一級高
U.S. FDA Grants Accelerated Approval to Bayer's HYRNUO (sevabertinib) as a First-Line Targeted Therapy for Patients with HER2-Mutated Non-Small Cell Lung Cancer2026-09-09BioSpace（轉載Bayer官方新聞稿全文）第一級高（公司官方新聞稿全文轉載）
FDA approves belzutifan in combination with lenvatinib for advanced renal cell carcinoma2026-09-24U.S. FDA第一級高
FDA Approves Atezolizumab in Combination with Chemotherapy for Stage III Mismatch Repair Deficient Colon Cancer2026-10-08U.S. FDA第一級高
Jemperli (dostarlimab-gxly) approved in US as first and only immunotherapy for adults with MSI-H/dMMR locally advanced rectal cancer2026-10-19GSK（官方新聞稿）第一級高
Ionis partner GSK announces Hibsago (bepirovirsen) approved in the U.S. for the treatment of chronic hepatitis B (CHB)2026-10-20GSK（BioSpace轉載公司公告）第一級高（公司公告原文）