1. https://adisinsight.springer.com/
2. https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review#:~:text=Fast%20track%20is%20a%20process,Priority%20Review
3. https://bgtcplaybook.document360.io/docs/expedited-pathways-and-designations
4. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track#:~:text=Fast%20Track%20is%20a%20process%20that%20helps,Application%20(NDA)%20for%20review%20by%20the%20FDA.
5. https://synergbiopharma.com/blog/how-long-does-fda-approval-take-after-phase-three/#:~:text=Priority%20review%20designation%20means%20the,or%20prevention%20of%20serious%20conditions.
6. https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program#:~:text=Press%20Announcements-,FDA%20Approves%20First%20New%20Molecular%20Entity%20Under%20National%20Priority%20Voucher,one%20weight%2Drelated%20comorbid%20condition.
7. https://www.intelacia.com/2026/02/13/5-fda-drug-approvals-that-could-shape-biotech-in-2026/#:~:text=The%20landscape%20of%20FDA%20Approvals,innovation%20strategy%2C%20and%20market%20positioning.
8. https://www.pharmtech.com/view/fda-s-50-day-nme-approval-changes-drug-development-rules#:~:text=Foundayo's%20safety%20profile%20is%20consistent,%2C%20vomiting%2C%20and%20abdominal%20pain.&text=The%20drug's%20labeling%20includes%20a,used%20with%20certain%20other%20medications.&text=The%20FDA's%20acting%20CDER%20director,empty%20stomach%2C%E2%80%9D%20H%C3%B8eg%20said.&text=The%20FDA%20plans%20to%20hold,this%20historic%20first%20NME%20approval.
9. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
10. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy#:~:text=Breakthrough%20Therapy%20designation%20is%20a,clinically%20significant%20endpoint(s).
11. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review#:~:text=A%20Priority%20Review%20designation%20directs%20attention%20and,safety%20and%20effectiveness%20in%20a%20new%20subpopulation
12. https://themmrf.org/glossary/priority-review/#:~:text=Designation%20assigned%20to%20a%20drug,that%20address%20unmet%20medical%20needs.
13. https://www.masuuglobal.com/what-is-orphan-drug-designation-odd/
14. https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products#:~:text=The%20FDA%20has%20the%20authority%20to%20designate,any%20other%20drug%20for%20approval%20or%20licensing.
15. https://bgtcplaybook.document360.io/docs/orphan-drug-designation-1
16. https://www.ispor.org/docs/default-source/intl2024/ispor24ronnebaump28presentation138089-pdf.pdf?sfvrsn=2a1d2da_0#:~:text=Page%206,6
17. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track#:~:text=Fast%20track%20is%20a%20process,improved%20effect%20on%20serious%20outcomes
18. https://pmc.ncbi.nlm.nih.gov/articles/PMC10391045/
19. https://jamanetwork.com/journals/jama/fullarticle/2687847
20. https://bpspubs.onlinelibrary.wiley.com/doi/10.1002/bcp.70486?af=R#:~:text=The%20use%20of%20expedited%20pathways,evidence%20where%20this%20was%20required.&text=This%20systematic%20review%20aimed%20to,?%20(cost%2Deffectiveness).
21. https://www.fda.gov/drugs/development-approval-process-drugs#:~:text=Accelerated%20Approval,significant%20impact%20on%20disease%20course.
22. https://www.contractpharma.com/the-2026-biologics-wave-which-innovations-will-break-through/#:~:text=Features-,The%202026%20Biologics%20Wave:%20Which%20Innovations%20Will%20Break%20Through?,4%2C5
23. https://cromospharma.com/rare-disease-day-2026-a-new-economic-reality-for-pharma/#:~:text=The%20structural%20imbalance%20remains%20stark,precision%20targeting%20rather%20than%20volume.
24. https://www.targetedonc.com/view/fda-oncology-update-january-2026-new-horizons-in-precision-medicine
25. https://trial.medpath.com/news/44bed2cc87ddc99e/fda-breakthrough-therapy-designation-shows-72-approval-success-rate-in-decade-long-analysis
26. https://cromospharma.com/rare-disease-day-2026-a-new-economic-reality-for-pharma/#:~:text=The%20structural%20imbalance%20remains%20stark,precision%20targeting%20rather%20than%20volume.
27. https://www.cancernetwork.com/view/fda-grants-fast-track-designation-to-fg001-for-high-grade-glioma-surgery#:~:text=The%20granting%20of%20fast%20track,based%20phase%202%20registration%20trial.&text=The%20IND%20was%20initially%20submitted%20to%20the%20FDA%20in%20January%202026.&text=Currently%2C%20the%20developer%20plans%20to,FluoGuide%2C%20in%20the%20press%20release.&text=%E2%80%9CWe%20greatly%20value%20the%20opportunity,patients%20facing%20this%20devastating%20cancer.%E2%80%9D
28. https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-october-2025
29. https://www.cancernetwork.com/view/fda-grants-fast-track-designation-to-daretabart-for-high-risk-neuroblastoma#:~:text=The%20FDA%20has%20granted%20fast,the%20developer%2C%20Renaissance%20Pharma%20Limited.&text=Concurrent%20with%20the%20designation%2C%20the,patients%20with%20high%2Drisk%20neuroblastoma.
30. https://www.mabion.eu/science-hub/articles/innovative-biologics-expected-approvals-in-2026/#:~:text=With%20AI%20accelerating%20discovery%20and,and%20improving%20outcomes%20for%20millions.
31. https://www.onclive.com/view/fda-grants-fast-track-designation-to-ibi3003-in-relapsed-refractory-multiple-myeloma?
32. https://www.fda.gov/drugs/nda-and-bla-approvals/fast-track-approvals?
33. https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-january-2026?
34. https://www.onclive.com/view/fda-grants-fast-track-designation-for-etx-19477-in-brca-mutated-platinum-resistant-hgsoc?
35. https://forbion.com/news-insights/news/complement-therapeutics-announces-fda-fast-track-designation-for-ctx001-for-the-treatment-of-geographic-atrophy-secondary-to-amd/?
36. https://finance.yahoo.com/news/altimmune-receives-fda-breakthrough-therapy-123000425.html?
37. https://investors.oculis.com/news-releases/news-release-details/oculis-announces-us-fda-breakthrough-therapy-designation-granted?
38. https://www.ipsen.com/press-release/u-s-fda-grants-ipsens-ipn60340-ict01-breakthrough-therapy-designation-in-first-line-unfit-acute-myeloid-leukemia-3218133/?
39. https://www.biospace.com/press-releases/alixorexton-granted-breakthrough-therapy-designation-by-u-s-fda-for-the-treatment-of-narcolepsy-type-1?
40. https://www.globenewswire.com/news-release/2026/01/05/3212690/0/en/Protara-Therapeutics-Receives-Both-FDA-Breakthrough-Therapy-and-Fast-Track-Designations-for-TARA-002-in-Pediatric-Patients-with-Lymphatic-Malformations.html
41. https://www.pharmaceutical-technology.com/news/fda-status-biogens-litifilimab-cle/?
42. https://www.targetedonc.com/view/fda-grants-btd-to-sofetabart-mipitecan-for-platinum-resistant-ovarian-cancer?
43. https://www.jnj.com/media-center/press-releases/rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-receives-u-s-fda-breakthrough-therapy-designation-for-patients-with-advanced-head-and-neck-cancer?
44. https://www.bayer.com/media/en-us/bayer-receives-breakthrough-therapy-designation-in-the-us-and-china-for-sevabertinib-as-a-first-line-treatment-for-patients-with-her2-mutant-non-small-cell-lung-cancer/?
45. https://www.yahoo.com/news/articles/where-u-science-hit-hardest-155326200.html
46. https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program#:~:text=As%20of%20December%2031%2C%202025,and%20CBER%20has%20granted%2020.
47. https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications#:~:text=Table_title:%20Oncology%20(Cancer)/Hematologic%20Malignancies%20Approval%20Notifications%20Table_content:,BRAF%20V600E%20mutation%20%7C%20Date:%202/24/2026%20%7C
48. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell
49. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026
50. https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program
51. https://biomedpharmajournal.org/vol18no3/a-comprehensive-review-of-us-fda-novel-drug-approvals-from-2013-2022-an-observational-study/#:~:text=On%20average%2C%2012%25%20(N=122)%20of%20novel%20drugs,approval%2C%20while%2016%25%20(N=155)%20received%20fast%2Dtrack%20approval.
52. https://healthark.ai/pressreleases/2023-fda-drug-highlights-key-approvals-pharma-outlook/#:~:text=Out%20of%20those%2C%2020%20(36%25)%20of%20the,in%20bringing%20out%20therapies%20to%20the%20market.
53. https://bla-regulatory.com/fda-drug-approval-trends-2024-2025/#:~:text=Steady%20Growth%20of%20Fast%20Track,plans%20from%20the%20earliest%20stages.
54. https://www.fda.gov/news-events/fda-voices/cder-brings-many-safe-and-effective-therapies-patients-and-consumers-2024
55. https://www.yakhak.org/journal/view.html?doi=10.17480/psk.2025.69.6.546#:~:text=Among%20428%20new%20drugs%20approved,time%20for%20Priority%20Review%20drugs.
56. https://www.nature.com/articles/d41573-026-00001-z#:~:text=The%20US%20FDA%20approved%2046%20new%20drugs,a%20tumultuous%20year%20at%20the%20regulatory%20agency.
57. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025#:~:text=In%202025%2C%20CDER%20approved%2046%20new%20drugs,also%20made%20other%20important%20approval%20decisions%2C%20such
58. https://www.fda.gov/media/190705/download?attachment#:~:text=Such%20drugs%20are%20not%20included,not%20meet%20priority%20review%20criteria.)&text=33%25%20of%20novel%20drugs%20approved%20received%20breakthrough%20therapy%20designation.&text=21%20of%20the%2046%20novel,in%202025%20received%20priority%20review.&text=CDER%20approved%2011%20of%20the,likely%20to%20predict%20clinical%20benefit.
59. https://www.fda.gov/files/drugs/published/new-drug-therapy-2025-annual-report.pdf#:~:text=Breakthrough%20Therapy%20CDER%20designated%2018%20of%20the,drug%20development%2C%20including%20involvement%20from%20senior%20managers.
60. https://pmc.ncbi.nlm.nih.gov/articles/PMC11657587/
61. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2792372
62. https://www.amjmed.com/article/S0002-9343(21)00276-X/pdf#:~:text=In%202020%2C%20the%20US%20Food,drugs%20approved%20by%20the%20US
63. https://www.fda.gov/news-events/fda-voices/cder-brings-many-safe-and-effective-therapies-patients-and-consumers-2024#:~:text=CDER's%20Effectiveness%20Bringing%20New%20Therapies,serious%20or%20life%2Dthreatening%20conditions.
64. https://www.soci.org/news/2025/1/the-fda-approved-these-50-new-drugs-in-2024#:~:text=The%20CDER%20also%20approved:%20*%20Over%2050%25,first%20vaccine%20to%20protect%20adults%20from%20Chikungunya
65. https://www.fda.gov/media/190705/download?attachment
66. https://www.soci.org/news/2025/1/the-fda-approved-these-50-new-drugs-in-2024#:~:text=Reducing%20the%20time%20to%20get,or%20prevention%20of%20serious%20conditions.
67. https://phslrx.com/first-in-class-therapies-top-list-of-fda-2024-novel-approvals/#:~:text=Expedited%20development%20and%20review%20pathways,long%20as%20they%20remain%20available.
68. https://www.fda.gov/patients/rare-diseases-fda?
69. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm
70. https://pubmed.ncbi.nlm.nih.gov/35548705/
71. https://www.fda.gov/drugs/novel-drug-approvals-fda/new-drug-therapy-approvals-2022#:~:text=In%202022%2C%2021%20of%20the,included%20in%20the%20list%20below.)
72. https://biomedpharmajournal.org/vol18no3/a-comprehensive-review-of-us-fda-novel-drug-approvals-from-2013-2022-an-observational-study/#:~:text=About%20374%20(87%25)%20of%20the%20428%20medicines,cycle%20approvals%2C%20averaging%2037%20drugs%20per%20year.
73. https://www.uspharmacist.com/article/recent-trends-in-approvals-of-novel-drugs?amp&filter=all&&utm_source=agorapulse&utm_medium=facebook&utm_campaign=02-02-20
74. https://www.sciencedirect.com/science/article/pii/S0223523421001331#:~:text=Moreover%2C%2026%20new%20drugs%20received,18%5D%2C%20%5B19%5D%5D.
75. https://www.pfizer.com/news/press-release/press-release-detail/fda-grants-priority-review-hympavzir-marstacimab-sbla#:~:text=Medicines-,FDA%20Grants%20Priority%20Review%20for%20HYMPAVZI%C2%AE%20(marstacimab)%20sBLA%20for,13%20min%20read
76. https://finance.yahoo.com/news/fda-grants-priority-review-hympavzi-114500775.html
77. https://join.targetedonc.com/view/frontline-obinutuzumab-receives-fdas-priority-review-for-follicular-lymphoma#:~:text=Ninety%2Dtwo%20percent%20of%20patients,Abstract%20650.
78. https://www.astrazeneca.com/media-centre/press-releases/2026/datroway-granted-priority-review-in-the-us-as-1st-line-treatment-for-patients.html#:~:text=candidates%20for%20immunotherapy-,Datroway%20granted%20Priority%20Review%20in%20the%20US%20as%201st%2Dline,PUBLISHED%203%20February%202026
79. https://www.astrazeneca-us.com/media/press-releases/2026/DATROWAY-datopotamab-deruxtecan-dlnk-granted-Priority-Review-in-the-US-as-1st-line-treatment-for-patients-with-metastatic-triple-negative-breast-cancer-who-are-not-candidates-for-immunotherapy.html#:~:text=The%20Food%20and%20Drug%20Administration,the%20second%20quarter%20of%202026.
80. https://www.onclive.com/view/fda-grants-priority-review-to-frontline-dato-dxd-for-metastatic-tnbc-ineligible-for-immunotherapy#:~:text=The%20FDA%20granted%20priority%20review%20to%20Dato%2DDXd,TNBC%20who%20are%20not%20eligible%20to%20receive
81. https://fgk-group.com/fgk-rs/services/orphan-medicinal-products-drugs/?gad_source=1&gad_campaignid=21330056390&gbraid=0AAAAAqZa4uoiANwHYnT1rxp8Q9TPOYs3O&gclid=CjwKCAjw46HPBhAMEiwASZpLRCqEY9KobhBeTjOG8FElVId-71mmT8ZNAYWGRRV3wq6z0BLREgFCaxoCGdYQAvD_BwE
82. https://www.sanofi.com/en/media-room/press-releases/2026/2026-03-02-06-00-00-3247008
83. https://www.prnewswire.com/news-releases/pegrizeprument-granted-orphan-drug-designation-for-prevention-of-organ-rejection-in-heart-transplant-patients-302749183.html#:~:text=Pegrizeprument%20is%20a%20pegylated%20monoclonal,the%20lives%20of%20transplant%20patients.
84. https://www.curetoday.com/view/fda-grants-orphan-drug-designation-to-zenocutuzumab-for-cholangiocarcinoma#:~:text=The%20U.S.%20Food%20and%20Drug,accelerate%20development%20of%20zenocutuzumab%2Dzbco.
85. https://ir.lanternpharma.com/news-1/news/news-details/2026/Lantern-Pharmas-LP-284-Receives-FDA-Orphan-Drug-Designation-for-Soft-Tissue-Sarcomas/default.aspx#:~:text=Lantern%20Pharma%20Inc%20%2D%20Lantern%20Pharma's,Designation%20for%20Soft%20Tissue%20Sarcomas
86. https://www.prnewswire.com/news-releases/global-orphan-drugs-market-is-anticipated-to-cross-usd-350-billion-by-2032--delveinsight-302702130.html
87. https://ir.soligenix.com/2026-02-26-Soligenix-Receives-Positive-Opinion-from-the-European-Medicines-Agency-on-the-Request-for-Orphan-Drug-Designation-for-SGX945-for-the-Treatment-of-Behcets-Disease#:~:text=Soligenix%20Receives%20Positive%20Opinion%20from,Beh%C3%A7et's%20Disease%20%2D%20Feb%2026%2C%202026
88. https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-november-2025
89. https://www.oncologynewscentral.com/drugs/info/oncology-drugs-granted-fda-designations-in-august-2025
90. https://www.oncologynewscentral.com/drug/oncology-drugs-granted-fda-designations-in-march-2025
91. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025#:~:text=What%20are%20%22Novel%22%20Drugs?,novel%20drugs%20approvals%20for%202025.
92. https://pmc.ncbi.nlm.nih.gov/articles/PMC10791980/
93. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2792372
94. https://www.yakhak.org/journal/view.html?uid=3448&&vmd=Full#:~:text=Among%20428%20new%20drugs%20approved%20during%20the,Track%20and%20122%20received%20Breakthrough%20Therapy%20designations.
95. https://pmc.ncbi.nlm.nih.gov/articles/PMC7844812/
96. https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-march-2026?
97. https://www.parexel.com/insights/blog/fda-novel-oncology-drug-approvals-in-2025-trends-and-strategic-insights-for-developers?
98. https://www.fda.gov/about-fda/accelerating-rare-disease-cures-arc-program/rare-disease-drug-approvals?
99. https://www.parexel.com/insights/new-medicines-novel-insights/advancing-rare-disease-drug-development/effective-regulatory-strategies/timing-and-data-are-critical-winning-breakthrough-therapy-designation-rare-disease-drugs?
100. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026?
101. https://www.fda.gov/vaccines-blood-biologics/cber-rare-disease-program?
102. https://www.fda.gov/drugs/guidances-drugs/guidance-documents-rare-disease-drug-development?
103. https://www.fda.gov/news-events/press-announcements/fda-launches-framework-accelerating-development-individualized-therapies-ultra-rare-diseases?
104. https://checkrare.com/2026-orphan-drugs-pdufa-dates-and-fda-approvals/?
105. https://alirahealth.com/education-hub/fda-initiatives-and-programs-to-support-development-of-treatments-for-rare-diseases-in-2025/?
106. https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review?
107. https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program?
108. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track?
109. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval?
110. https://www.hks.harvard.edu/centers/mrcbg/programs/growthpolicy/fda-breakthrough-therapy-designation-reduced-late-stage-drug?
111. https://pubmed.ncbi.nlm.nih.gov/38950306/
112. https://www.fda.gov/news-events/press-announcements/cms-and-fda-announce-rapid-coverage-pathway-accelerate-patient-access-life-changing-medical-devices?
113. https://www.fda.gov/patients/rare-diseases-fda?
114. https://www.fda.gov/industry/grant-programs-support-development-medical-products-rare-diseases/orphan-products-grants-program?
115. https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/fda-rare-disease-innovation-hub?
116. https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/economic-assistance-and-incentives-drug-development?
117. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-proposes-framework-speed-rare-disease-gene-therapy-approvals-2026-02-23/?
118. https://www.fda.gov/patients/rare-diseases-fda?
119. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track?
120. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review
121. https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program
122. https://www.reuters.com/business/healthcare-pharmaceuticals/
123. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval
124. https://www.raps.org/resource/accelerated-approval-fda-explains-when-it-consider.html?
125. https://www.raps.org/resource/accelerated-approval-fda-explains-when-it-consider.html?
126. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval?
127. https://www.raps.org/resource/accelerated-approval-fda-explains-when-it-consider.html?
128. https://www.reuters.com/legal/litigation/us-fdas-accelerated-approval-drugs-needs-more-transparency-says-research-firm-2026-04-16/?
129. https://icer.org/wp-content/uploads/2026/04/Strengthening-the-FDAs-Accelerated-Approval-Pathway-_-ICER-White-Paper-_-April-2026.pdf?
130. https://www.biospace.com/press-releases/fda-grants-priority-review-for-hympavzi-marstacimab-sbla-for-the-treatment-of-two-hemophilia-a-or-b-patient-populations-with-significant-medical-need?
131. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026?
132. https://icer.org/wp-content/uploads/2026/04/Strengthening-the-FDAs-Accelerated-Approval-Pathway-_-ICER-White-Paper-_-April-2026.pdf?
133. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026?
134. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026?
135. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026?
136. https://icer.org/wp-content/uploads/2026/04/Strengthening-the-FDAs-Accelerated-Approval-Pathway-_-ICER-White-Paper-_-April-2026.pdf?
137. https://www.reddit.com/r/Hemophilia/comments/1qxgmj0/fda_grants_priority_review_for_hympavzi/?
138. https://www.reddit.com/r/NervGen_NerveRepair/comments/1su6eoz/nervgens_response_regarding_accelerated_approval/?
139. https://www.reuters.com/legal/litigation/us-fdas-accelerated-approval-drugs-needs-more-transparency-says-research-firm-2026-04-16/?
140. https://www.fda.gov/news-events/press-announcements/fda-approves-drug-treat-neurologic-manifestations-hunter-syndrome?
141. https://www.drugs.com/history/avlayah.html?
142. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026?
143. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026?
144. https://icer.org/news-insights/press-releases/icer-white-paper-on-accelerated-approval-pathway-2026/?
145. https://icer.org/assessment/fda-accelerated-approval-pathway-2026/?
146. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026?
147. https://www.pharmavoice.com/news/fda-drug-approval-takeda-novo-merck-lilly-2026/808924/?
148. https://www.drugs.com/newdrugs.html?
149. https://www.reuters.com/legal/litigation/us-fda-monitor-clinical-trial-data-real-time-pilot-program-aimed-speeding-2026-04-28/?
150. https://icer.org/wp-content/uploads/2026/04/Strengthening-the-FDAs-Accelerated-Approval-Pathway-_-ICER-White-Paper-_-April-2026.pdf?
151. https://www.reuters.com/legal/litigation/us-fdas-accelerated-approval-drugs-needs-more-transparency-says-research-firm-2026-04-16/?
152. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026?
153. https://www.pharmavoice.com/news/fda-drug-approval-takeda-novo-merck-lilly-2026/808924/?
154. https://www.drugs.com/newdrugs.html?
155. https://www.reuters.com/legal/litigation/us-fda-monitor-clinical-trial-data-real-time-pilot-program-aimed-speeding-2026-04-28/?
156. https://icer.org/wp-content/uploads/2026/04/Strengthening-the-FDAs-Accelerated-Approval-Pathway-_-ICER-White-Paper-_-April-2026.pdf?
157. https://www.reuters.com/legal/litigation/us-fdas-accelerated-approval-drugs-needs-more-transparency-says-research-firm-2026-04-16/?
158. https://sherwood.news/business/big-pharma-enters-2026-with-an-appetite-for-deals/
159. https://www.gibsondunn.com/wp-content/uploads/2026/01/Life-Sciences_2026-Outlook-Brochure.pdf
160. https://pharma.economictimes.indiatimes.com/news/pharma-industry/big-pharma-ma-set-for-mega-year-as-patent-expiries-drive-deal-urgency/130730270
161. https://www.twobirds.com/en/insights/2026/china/china's-pharmaceutical-regulatory-update-faster-routes-to-market,-stronger-ip-and-data-protection
162. https://finance.yahoo.com/news/ai-agents-healthcare-market-set-143000370.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAIeyTDKUk5iS_xrYc0CXmkswiG982QUbl1E_NCgI2liLfYoqJj_hIGCvldn-uuxz7mD2t7V68K6gsZYYR2r5tY1vpPowEm1pyFTObFA9EC-VHWEK_h2jxaQhzrEpqnYIjPrB90-MeGsdq7aP_jRPeB3w7q5mI4sxEN1io1fIub9u
163. https://finance.yahoo.com/news/ai-agents-healthcare-market-set-143000370.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAIeyTDKUk5iS_xrYc0CXmkswiG982QUbl1E_NCgI2liLfYoqJj_hIGCvldn-uuxz7mD2t7V68K6gsZYYR2r5tY1vpPowEm1pyFTObFA9EC-VHWEK_h2jxaQhzrEpqnYIjPrB90-MeGsdq7aP_jRPeB3w7q5mI4sxEN1io1fIub9u
164. https://www.laboratoriosrubio.com/en/pharmas-biotech-ma/
165. https://www.bioxconomy.com/investment/biopharma-dealmaking-surges-in-q1-as-industry-shifts-to-risk-averse-capital-strategies
166. https://visionlifesciences.com/insights/biotech-licensing-deal-tracker-2026
167. https://www.bioxconomy.com/investment/biopharma-dealmaking-surges-in-q1-as-industry-shifts-to-risk-averse-capital-strategies
168. https://www.decibio.com/insights/pharma-services-in-review-2025-events-to-shape-2026
169. https://www.intelacia.com/2026/02/15/top-10-biopharma-ma-deals-of-2025-and-pharma-patent-strategies-backing-them/
170. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
https://visionlifesciences.com/insights/nmpa-drug-approval-process-guide
171. https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-january-2026
172. https://www.yahoo.com/news/articles/fda-breakthrough-program-starts-fy2026-022825693.html
173. https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program#:~:text=As%20of%20December%2031%2C%202025,and%20CBER%20has%20granted%2020.
174. https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications#:~:text=Table_title:%20Oncology%20(Cancer)/Hematologic%20Malignancies%20Approval%20Notifications%20Table_content:,BRAF%20V600E%20mutation%20%7C%20Date:%202/24/2026%20%7C
175. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026
176. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell#:~:text=cell%20lung%20cancer-,FDA%20grants%20accelerated%20approval%20to%20zongertinib%20for%20unresectable%20or%20metastatic,non%2Dsmall%20cell%20lung%20cancer&text=On%20February%2026%2C%202026%2C%20the,be%20posted%20on%20Drugs@FDA.
177. https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program
178. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval#:~:text=These%20regulations%20allowed%20drugs%20for%20serious%20conditions,Administration%20)%20to%20approve%20these%20drugs%20faster.
179. https://ir.ionis.com/news-releases/news-release-details/ionis-announces-zilganersen-new-drug-application-alexander#:~:text=%E2%80%93%20PDUFA%20date%20set%20for%20September,marking%20a%20breakthrough%20for%20patients.
180. https://www.targetedonc.com/
181. https://www.primetherapeutics.com/fda-decisions-expected-april-2026#:~:text=2Q%202026:%20baxdrostat,of%20Prime's%20Quarterly%20Drug%20Pipeline.
182. https://www.yakhak.org/journal/view.html?doi=10.17480/psk.2025.69.6.546
183. https://www.businesswire.com/news/home/20260522569258/en/FDA-Grants-Accelerated-Approval-to-Gileads-Hepcludex-bulevirtide-gmod-the-First-and-Only-Approved-Treatment-for-Chronic-Hepatitis-Delta-Virus-HDV
184. https://springbiosolution.com/blogs/fda-drug-approvals-march-2026/
185. https://www.zacks.com/stock/news/2929063/fda-grants-priority-review-to-snys-filing-for-gaucher-disease-drug
186. https://www.thecardiologyadvisor.com/news/fda-drug-approval-decisions-expected-in-june-2026/
187. https://www.rheumatologyadvisor.com/news/fda-drug-approval-decisions-expected-in-february-2026/
188. https://www.onclive.com/view/fda-grants-priority-review-to-neladalkib-for-tki-pretreated-alk-nsclc
189. https://www.merck.com/news/fda-grants-priority-review-for-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-with-padcev-enfortumab-vedotin-ejfv-for-cisplati/
190. https://www.rheumatologyadvisor.com/news/fda-grants-priority-review-to-efgartigimod-for-seronegative-gmg/
191. https://www.thecardiologyadvisor.com/news/fda-drug-approval-decisions-expected-in-june-2026/
192. https://www.bayer.com/en/us/news-stories/kerendiar-granted-priority-review
193. https://www.cancernetwork.com/view/fda-accepts-nda-grants-priority-review-bezuclastinib-sunitinib-pretreated-gist
194. https://www.merck.com/news/fda-grants-breakthrough-therapy-designation-for-calderasib-mk-1084-an-investigational-kras-g12c-inhibitor-for-certain-patients-with-newly-diagnosed-metastatic-kras-g12c-mutant-non-small-cell-lung/
195. https://www.targetedonc.com/view/fda-grants-breakthrough-therapy-designation-to-emiltatug-ledadotin-for-adenoid-cystic-carcinoma
196. https://www.psychiatryadvisor.com/news/elunetirom-fast-track-designation-bipolar-depression/
197. https://www.targetedonc.com/view/fda-grants-fast-track-designation-to-suplexa-for-msi-h-colorectal-cancer
198. https://www.dermatologytimes.com/view/fda-grants-fast-track-designation-to-doc1021-for-unresectable-or-metastatic-cutaneous-melanoma
199. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma