breakthrough therapies

Stakeholders ask FDA to be more flexible on rescinding breakthrough drugs designations
RAPS.org
Sun, 08/28/22 - 10:17 pm
FDA
regulatory
breakthrough therapies
FDA Grants vTv’s Type 1 Diabetes Drug Breakthrough Therapy Designation
BioSpace
Tue, 04/13/21 - 10:01 pm
vTv Therapeutics
TTP399
type 1 diabetes
breakthrough therapies
FDA
Roche gets FDA breakthrough therapy status for tiragolumab plus Tecentriq
Pharmaceutical Business Review
Wed, 01/6/21 - 10:37 am
Roche
FDA
tiragolumab
Tecentriq
non-small cell lung cancer
breakthrough therapies
Concert gets BTD for alopecia drug, setting up a late-stage showdown with giant rival Pfizer
Endpoints
Wed, 07/8/20 - 10:45 am
Concert Pharmaceuticals
alopecia areata
FDA
CTP-543
breakthrough therapies
Sunovion’s SEP-363856 gets FDA breakthrough status for schizophrenia
Pharmaceutical Business Review
Tue, 05/14/19 - 09:24 am
Sunovion
PsychoGenics
breakthrough therapies
SEP-363856
schizophrenia
Celgene gets FDA breakthrough therapy designation for Pomalyst to treat Kaposi sarcoma
Pharmaceutical Business Review
Tue, 05/14/19 - 09:23 am
Celgene
Pomalyst
breakthrough therapies
Kaposi's Sarcoma
FDA Rescinds Two Breakthrough Therapy Designations
RAPS.org
Sat, 03/9/19 - 12:36 pm
FDA
breakthrough therapies
clinical trials
Tonix Pharmaceuticals
Tonmya
Trevena
oliceridine
Lilly's third-to-market Emgality nets FDA 'breakthrough' in cluster headache
Fierce Pharma
Thu, 11/15/18 - 11:37 pm
Eli Lilly
Emgality
cluster headaches
FDA
breakthrough therapies
FDA Grants Breakthrough Therapy Designation to First Oral Drug for Suicidal Bipolar Depression
CP Wire
Tue, 11/13/18 - 09:44 am
NRX-101
NeuroRx
FDA
bipolar disorder
breakthrough therapies
Pfizer's Pneumococcal Conjugate Vaccine Awarded Breakthrough Therapy Designation
CP Wire
Thu, 09/20/18 - 11:14 am
Pfizer
streptococcus pneumoniae
vaccines
breakthrough therapies
FDA
FDA Grants Pfizer's Xalkori Breakthrough Therapy Status for Two New Indications
CP Wire
Tue, 05/29/18 - 10:37 am
Pfizer
Xalkori
metastatic non-small cell lung cancer
FDA
breakthrough therapies
anaplastic large-cell lymphoma
J&J’s blockbuster hopeful erdafitinib gets ‘breakthrough’ moniker
Endpoints
Thu, 03/15/18 - 09:56 am
JNJ
erdafitinib
breakthrough therapies
metastatic urothelial cancer
Zogenix wins inside track at FDA with childhood epilepsy ‘breakthrough’
Endpoints
Tue, 02/6/18 - 09:24 am
Zogenix
FDA
epilepsy
Dravet syndrome
ZX008
breakthrough therapies
The stellar antibody shop at Regeneron wins a ‘breakthrough’ tag for its next big PhIII drug
Endpoints
Fri, 04/7/17 - 09:48 am
Regeneron
breakthrough therapies
evinacumab
LDL cholesterol
Big Pharma benefits more from breakthrough therapy designations: report
BioPharma Dive
Wed, 08/3/16 - 09:19 am
Big Pharma
breakthrough therapies
Novartis pill gets U.S. breakthrough designation in breast cancer
Yahoo/Reuters
Wed, 08/3/16 - 09:14 am
Novartis
breakthrough therapies
breast cancer
LEE011
AbbVie Inc Bags Fourth Breakthrough Therapy Status for Imbruvica
Bidness, ETC
Thu, 06/30/16 - 09:35 am
AbbVie
breakthrough therapies
Imbruvica
cGVHD
graft vs host disease
Bristol-Myers Squibb Co Wins a Sixth Breakthrough Tag for Opdivo
Bidness, ETC
Tue, 06/28/16 - 05:23 pm
Bristol-Myers Squibb
Opdivo
breakthrough therapies
bladder cancer
FDA
Bristol-Myers Squibb's bladder cancer treatment granted breakthrough therapy designation
Marketwatch
Mon, 06/27/16 - 10:28 am
Bristol-Myers Squibb
bladder cancer
breakthrough therapies
FDA
Opdivo
FDA Grants Breakthrough Therapy Designation for Incyte’s Ruxolitinib (Jakafi®) in Acute Graft-Versus-Host Disease (GVHD)
Yahoo
Fri, 06/24/16 - 09:15 am
FDA
Incyte
Jakafi
breakthrough therapies
graft vs host disease

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