breakthrough therapy

Biogen Receives U.S. FDA Breakthrough Therapy Designation for Felzartamab for the Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients
Drugs.com
Sun, 10/13/24 - 11:30 am
Biogen
felzartamab
FDA
breakthrough therapy
kidney transplants
Concert persuades FDA to keep breakthrough tag for alopecia therapy despite Lilly's arrival
Fierce Biotech
Wed, 02/15/23 - 10:48 am
Concert Pharmaceuticals
alopecia areata
FDA
breakthrough therapy
deuruxolitinib
Eli Lilly
olumiant
Moderna Granted FDA Breakthrough Therapy Designation for mRNA-1345, An Investigational Respiratory Syncytial Virus (RSV) Vaccine Candidate
BioSpace
Mon, 01/30/23 - 10:37 am
Moderna Therapeutics
FDA
mRNA-1345
vaccines
RSV
breakthrough therapy
Pfizer’s Elranatamab Granted FDA Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma
Drugs.com
Fri, 11/4/22 - 11:03 am
Pfizer
elranatamab
FDA
breakthrough therapy
relapsed or refractory multiple myeloma
Janssen secures FDA breakthrough designation for myeloma therapy
Pharmaceutical Business Review
Thu, 06/30/22 - 10:54 am
JNJ
Janssen
breakthrough therapy
FDA
talquetamab
Multiple Myeloma
relapsed or refractory multiple myeloma
Alzheimer’s Drug Granted FDA Breakthrough Designation as Space Heats Up
BioSpace
Mon, 10/11/21 - 09:48 pm
Roche
FDA
breakthrough therapy
Alzheimer's disease
gantenerumab
Roche's Gantenerumab Gets FDA Breakthrough Therapy Designation for Alzheimer's Disease
Marketwatch
Sat, 10/9/21 - 10:58 pm
Roche
FDA
gantenerumab
Alzheimer's disease
breakthrough therapy
How AbbVie Could Make an Entry Into This Rapidly Growing Drug Market
Motley Fool
Thu, 07/29/21 - 11:12 am
AbbVie
Roche
Venclexta
MDS
breakthrough therapy
Pneumococcal Vaccine Snags Breakthrough Therapy Designation
BioSpace
Tue, 07/13/21 - 11:29 pm
Astellas
Affinivax
vaccines
pneumococcal disease
breakthrough therapy
Novartis sets the tone for the radiopharma push with a prized acquisition winning breakthrough therapy designation
Endpoints
Thu, 06/17/21 - 11:09 am
Novartis
radiopharmaceuticals
breakthrough therapy
FDA
Lu-PSMA-617
Immunocore gets FDA breakthrough nod for eye melanoma drug ahead of planned Q3 filing
Fierce Biotech
Fri, 02/19/21 - 10:28 am
Immunocore
FDA
uveal melanoma
breakthrough therapy
tebentafusp
Novartis gets FDA breakthrough therapy status for ligelizumab to treat chronic spontaneous urticaria
Pharmaceutical Business Review
Fri, 01/15/21 - 09:49 am
Novartis
breakthrough therapy
FDA
ligelizumab
chronic spontaneous urticaria
Novo Nordisk quietly nabs a rare 'breakthrough' status in NASH for its cash cow
Endpoints
Fri, 10/30/20 - 10:25 am
Novo Nordisk
earnings
NASH
semaglutide
breakthrough therapy
FDA
The FDA hands Farxiga 'breakthrough' status in CKD, clearing path for AstraZeneca's much-touted therapy
Endpoints
Sun, 10/4/20 - 12:18 am
AstraZeneca
chronic kidney disease
FDA
breakthrough therapy
Farxiga
Gilead gets FDA breakthrough therapy status for magrolimab in MDS
Pharmaceutical Business Review
Wed, 09/16/20 - 10:37 am
Gilead Sciences
FDA
MDS
magrolimab
breakthrough therapy
AstraZeneca, Daiichi Sankyo get FDA breakthrough therapy status for gastric cancer drug
Pharmaceutical Business Review
Mon, 05/11/20 - 10:27 am
AstraZeneca
Daiichi Sankyo
FDA
Enhertu
gastric cancer
breakthrough therapy
Acceleron's PAH drug gets the FDA's red carpet treatment with breakthrough status
Endpoints
Wed, 04/8/20 - 10:37 am
Acceleron
PAH
FDA
breakthrough therapy
sotatercept
Lilly, Incyte get FDA breakthrough therapy status for baricitinib to treat alopecia areata
Pharmaceutical Business Review
Tue, 03/17/20 - 11:59 am
Eli Lilly
Incyte
breakthrough therapy
FDA
baricitinib
alopecia areata
J&J’s Experimental Lung Cancer Drug Receives Breakthrough Therapy Designation
BioSpace
Thu, 03/12/20 - 11:03 am
Janssen
JNJ
FDA
JNJ-6372
breakthrough therapy
metastatic non-small cell lung cancer
Genentech's Esbriet Granted Breakthrough Therapy Designation for uILD
BioSpace
Wed, 03/4/20 - 10:47 am
Genentech
Esbriet
uILD
breakthrough therapy
FDA

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