breakthrough status

Pfizer revs up to leave GSK in the dust as maternal RSV vax granted FDA breakthrough tag
Fierce Biotech
Wed, 03/2/22 - 12:16 pm
Pfizer
GSK
vaccines
RSV
PF-06482077
FDA
breakthrough status
Boehringer secures FDA’s Breakthrough Therapy Designation for oral therapy
Pharmaceutical Business Review
Fri, 02/25/22 - 09:58 am
Boehringer Ingelheim
idiopathic pulmonary fibrosis
FDA
BI 1015550
breakthrough status
Eisai-Biogen Alzheimer’s drug gets FDA breakthrough designation
Pharmaceutical Business Review
Thu, 06/24/21 - 10:56 am
Eisai
Biogen
FDA
lecanemab
breakthrough status
Alzheimer's disease
Enhertu picks up another win for AstraZeneca and Daiichi Sankyo, joining the priority review lane for gastric cancer
Endpoints
Wed, 10/28/20 - 10:32 am
AstraZeneca
Daiichi Sankyo
Enhertu
breakthrough status
FDA
metastatic gastric cancer
gastric cancer
Riding a PhII success, a small French biotech lands a rare 'breakthrough' status in NASH
Endpoints
Tue, 10/13/20 - 11:03 am
Inventiva
NASH
France
FDA
breakthrough status
lanifibranor
Sanofi, Regeneron get FDA breakthrough therapy status for Dupixent to treat eosinophilic esophagitis
Pharmaceutical Business Review
Mon, 09/14/20 - 10:50 am
Sanofi
Regeneron
Dupixent
FDA
eosinophilic esophagitis
breakthrough status
Takeda gets FDA breakthrough therapy status for pevonedistat to treat higher-risk HR-MDS
Pharmaceutical Business Review
Fri, 07/31/20 - 10:42 am
Takeda Pharmaceuticals
breakthrough status
FDA
pevonedistat
myelodysplastic syndrome
Bristol-Myers Squibb gets FDA breakthrough therapy status for Orencia to prevent GvHD
Pharmaceutical Business Review
Thu, 12/5/19 - 10:06 am
Bristol-Myers Squibb
Orencia
graft vs host disease
FDA
breakthrough status
7 Reasons for Medtech to Be Thankful in 2019
Medical Devices and Diagnostics Industry
Sat, 11/30/19 - 11:07 pm
devices
FDA
robotic surgery
breakthrough status
Medtronic
Abbott Labs
artificial intelligence
paclitaxel
3D printing
First 'Artificial Meniscus' Wins FDA Breakthrough Device Designation
Medical Devices and Diagnostics Industry
Thu, 09/19/19 - 07:55 pm
devices
FDA
breakthrough status
Active Implants
NUsurface
meniscus surgery
artificial meniscus
PhaseBio touts 'breakthrough' badge for bloodthinner reversal agent licensed from AstraZeneca, shares leap
Endpoints
Tue, 04/9/19 - 08:22 am
PhaseBio
Brilinta
PB2452
bloodthinner reversals
breakthrough status
AstraZeneca
When Biotechs Get Breakthrough Therapy Status, Mr. Market Yawns
Forbes
Sat, 02/23/19 - 04:57 pm
breakthrough status
FDA blesses Merck’s PhIII effort to topple a mega-blockbuster — but there’s also a little biotech in this game
Endpoints
Thu, 01/31/19 - 11:27 am
Merck
V114
vaccines
FDA
breakthrough status
Prevnar 13
Pfizer
FDA grants breakthrough status to joint Merck-Bayer AI program
Mass Device
Mon, 12/10/18 - 07:17 pm
Merck
Bayer
FDA
breakthrough status
devices
CTEPH
artificial intelligence
FDA waves Loxo through for second ‘breakthrough’ in tissue-agnostic cancer therapy
Endpoints
Wed, 09/5/18 - 10:32 am
Loxo Oncology
FDA
breakthrough status
LOXO-292
Sage to Expedite Development of SAGE-217 in Major Depressive Disorder and Postpartum Depression
CP Wire
Tue, 06/12/18 - 10:00 am
SAGE Therapeutics
FDA
breakthrough status
SAGE-217
major depressive disorder
postpartum depression
Gottlieb pushes back against criticism of ‘breakthrough’ designation
Stat
Mon, 05/7/18 - 09:55 am
FDA
breakthrough status
Scott Gottlieb
FDA Grants Breakthrough Therapy Status to Pfizer's Trumenba for Prevention of Meningococcal B Disease in Children
CP Wire
Mon, 04/23/18 - 09:15 am
Pfizer
Trumenba
vaccines
meningococcal B
FDA
breakthrough status
Roche gets double dose of good Hemlibra news with FDA breakthrough, ICER backing
Fierce Pharma
Tue, 04/17/18 - 11:33 am
Roche
Hemlibra
hemophilia
FDA
breakthrough status
ICER
Does the FDA’s ‘breakthrough’ drug program need to be reformed? Harvard skeptics say yes
Endpoints
Thu, 04/12/18 - 09:05 am
FDA
Harvard
breakthrough status

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