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Timeline of Regulatory Designations
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2A Pharma
2seventy bio
4D Molecular Tx
ASC Tx
AbbVie
Abeona Tx
Acadia Pharma
Adaptimmune Tx
Adicet Bio
Adrenas Tx
Adverum Biotech
Aegle Tx
Affimed
Affyimmune Tx
Akamis Bio
Akcea Tx
Akouos
Alaunos
AlloVir
Allogene Tx
Alnylam Pharma
Amarantus BioSci
Amgen
Amicus Tx
Amryt Pharma
AnGes
AnaptysBio
Antisense Tx
Apellis Pharma
Apic Bio
Arbutus Biopharma
Arcellx
Arcturus Tx
Arrowhead Pharma
Artiva BioTx
Aruvant
Asklepios BioPharma
Astellas Gene Therapies
Astellas Pharma
AstraZeneca
Atara BioTx
Athenex
Athersys
Atlantic Healthcare
Autolus Tx
AviadoBio
Avidity Biosci
Avita Medical
Avrobio
Bayer
Bellicum Pharma
Benitec Biopharma
Bio-Path Holdings
BioCardia
BioCryst
BioMarin Pharma
BioNTech
BioSyngen
Biogen
Biostage
BlueBird Bio
BlueRock Tx
Bone Tx
BrainStorm Cell Tx
Brainvectis
BridgeBio Pharma
Bristol Myers Squibb
CARsgen Tx
CBMG
CLS Tx
CRISPR Tx
CSL Behring
Cabaletta Bio
Canbridge Pharma
Candel Tx
Capricor Tx
Caribou Biosci
Carisma Tx
Catalyst Biosci
Celgene
Cell Cure Neurosci
Cellerant Tx
Cellevolve Bio
Cellvation
Celularity
Celyad Oncology
Coave Tx
Cook Myosite
Cour Pharma
Cyprium Tx
DCPrime B.V.
DNATriX
Daiichi Sankyo
Decibel Tx
Denali Tx
Dicerna Pharma
Disc Medicine
DiscGenics
DragonFly Tx
Dynacure
Dyne Tx
Editas Medicine
ElevateBio
Eli Lilly
Eloxx Pharma
Enzyvant
Eureka Tx
Excellthera
Exicure
Eyevensys
Fate Tx
Fibrocell
Flexion Tx
Forge Bio
Fortress Biotech
Freeline Tx
Fulcrum Tx
GC Pharma
GSK
Gamida Cell
GammaDelta Tx
GenMab
GenSight Biologics
GeneTx BioTx
GeneVentiv Tx
Genenta Sci
Genentech
Genprex
Genzyme
Gilead Sci
Glycostem
Gracell Bio
Graphite Bio
Gritstone Oncology
Gyroscope Tx
Hansa Biopharma
Helixmith
Herantis Pharma
Holostem Terapie Avanzate
Homology Medicines
ImmPACT bio
Immatics
Immunocore
Immunomedics
Immusoft
Imunon
Innovative Cellular Tx
Inovio Pharma
Intellia Tx
Ionis Pharma
Iovance BioTx
Iveric Bio
Ixaka
JCR Pharma
Jacobio Pharma
Janssen
Jasper Tx
Juventas Tx
Kiadis Pharma
Kite Pharma
Krystal Biotech
Kyverna Tx
Larimar Tx
Legend Biotech
Lexeo Tx
Lineage Cell Tx
Lion TCR
Lisata Tx
Locate Bio
LogicBio Tx
Lokon Pharma
Lysogene
Magenta Tx
Marker Tx
Maze Tx
Medeor Tx
MeiraGTx
Mendus
Merck and Co.
Mereo Biopharma
Mesoblast
MiMedx Group
Moderna
Mustang Bio
Myeloid Tx
Myrtelle
Nanoscope Tx
Neubase Tx
Neurimmune
Neurocrine Biosci
Neurophth Tx
NightHawk BioSci
Nippon Shinyaku
Nkarta Tx
Northwest BioTx
Novadip Biosci
Novartis
Novartis Gene Therapies
Novo Nordisk
OPKO Health
Ocugen
Odylia Tx
Omega Tx
OncoSec Medical
Oncotelic
Oncternal Tx
Orca Bio
Orchard Tx
PTC Tx
Palisade Bio
Passage Bio
Pfizer
Plus Tx
Polaryx Tx
Poseida Tx
Precigen
Precision Biosci
Prescient Tx
Prevail Tx
ProQR Tx
Q Tx
Reflection Biotech
Regeneron Pharma
Regenxbio
Regulus Tx
Renova Tx
Roche
Rocket Pharma
Roivant Sci
SOM Biotech
SOTIO
SQZ Biotech
Sangamo Tx
Sanofi
Sarepta Tx
Selecta Biosci
Servier Pharma
Shire
Sigilon Tx
Sio Gene Therapies
Smart Immune
Solid Biosci
Sorrento Tx
SparingVision
Spark Tx
Spirovant Sci
Springworks Tx
Stoke Tx
Summit Tx
TCR2 Tx
Takeda
TargaZyme
Targovax
Taysha GTx
TeamedOn International
Tenaya Tx
TeneoBio
Tessa Tx
Theradaptive
Tivorsan Pharma
Tocagen
Trillium Tx
Triumvira Immunologics
Ultragenyx Pharma
UniQure
United Tx
VAXIMM
VBL Tx
Vericel
Verismo Tx
Vertex Pharma
Viridian Tx
Vivet Tx
Vor Biopharma
Voyager Tx
Wave Life Sciences
Wugen
Xalud Tx
iECure
Orphan Drug (ODD) FDA
Orphan Drug (ODD) EMA
Breakthrough (BT)
Rare Pediatric Disease (RPDD)
Regenerative Medicine Advanced Therapy (RMAT)
Priority Medicine (PRIME)
Fast Track
Other
Orphan Drug (ODD) FDA
Orphan Drug (ODD) EMA
Breakthrough (BT)
Rare Pediatric Disease (RPDD)
Regenerative Medicine Advanced Therapy (RMAT)
Priority Medicine (PRIME)
Fast Track
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