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Home
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companies
» EMA
EMA
Janssen flags accelerated approval milestone in Europe for CAR-T therapy
Biopharma Reporter
Mon, 02/1/21 - 11:04 pm
JNJ
Janssen
CAR-T
EMA
Europe
cilta-cel
Cyberattack: EMA says leaked documents ‘manipulated’
RAPS.org
Sat, 01/16/21 - 11:40 pm
COVID-19
vaccines
EMA
cyberattack
cybersecurity
Hackers steal Pfizer, BioNTech data in EMA breach as cybersecurity attacks heat up
Endpoints
Thu, 12/10/20 - 11:11 am
cybersecurity
data breach
cyberattack
hackers
vaccines
EMA
Pfizer
BioNTech
COVID-19
Janssen combines Darzalex with COVID-19 drug in new multiple myeloma submission
Pharmaforum
Fri, 11/13/20 - 12:11 pm
Janssen
Multiple Myeloma
Darzalex
EMA
FDA
Why DBV Technologies Stock Is Soaring Today
Motley Fool
Mon, 11/2/20 - 11:04 pm
DBV Technologies
Viaskin Peanut
peanut allergy
Europe
EMA
Study: Few new drugs have high therapeutic value
RAPS.org
Mon, 10/12/20 - 08:17 pm
British Medical Journal
FDA
EMA
therapeutic value
drug approvals
Thinking the unthinkable on Covid vaccine approvals
EP Vantage
Wed, 10/7/20 - 11:04 am
COVID-19
pandemic
regulatory
FDA
EMA
Europe
vaccines
European Medicines Agency reviewing reports of kidney injury in patients taking Gilead's remdesivir
Beckers Hospital Review
Mon, 10/5/20 - 11:55 pm
EMA
Europe
Gilead Sciences
remdesivir
COVID-19
Takeda takes a $200M hit after Novartis is forced to yank its marketing application for Xiidra
Endpoints
Mon, 06/29/20 - 10:26 am
Takeda
Novartis
Xiidra
Europe
EMA
dry eye disease
Vertex : CHMP Grants Positive Opinion For KAFTRIO - KALYDECO In People Ages 12 And Older With CF
Business Insider
Fri, 06/26/20 - 07:47 pm
Vertex Pharmaceuticals
Europe
EMA
CHMP
cystic fibrosis
Kalydeco
Kaftrio
COVID-19 drug remdesivir recommended for EU approval
Pharmaforum
Fri, 06/26/20 - 09:43 am
Gilead
remdesivir
EMA
Europe
CHMP
COVID-19
Regulators discuss accelerated approvals, Project Orbis at DIA
RAPS.org
Wed, 06/17/20 - 10:46 am
regulatory
DIA
accelerated approvals
FDA
EMA
Health Canada
Drug regulators in agreement on coronavirus vaccine trials, FDA official says
BioPharma Dive
Tue, 06/9/20 - 11:22 pm
vaccines
pandemic
COVID-19
FDA
Health Canada
EMA
clinical trials
Gilead files remdesivir for EU approval, with a verdict possible “in weeks”
Pharmaforum
Tue, 06/9/20 - 10:36 am
EMA
Europe
Gilead Sciences
remdesivir
COVID-19
EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication
RAPS.org
Tue, 06/2/20 - 11:00 am
EMA
Europe
regulatory
clinical trial transparency
COVID-19
pandemic
EMA extends virtual-only meeting policy through August
Endpoints
Thu, 05/21/20 - 10:47 am
EMA
Europe
FDA
COVID-19
pandemic
CHMP backs BMS’ first-in-class anemia drug Reblozyl
Pharmaforum
Mon, 05/4/20 - 10:34 am
Bristol-Myers Squibb
EMA
CHMP
Reblozyl
anemia
Celgene
EMA gives thumbs up to key drugs from Novartis, Alexion, Vertex and more
Endpoints
Fri, 05/1/20 - 12:43 pm
EMA
Europe
Novartis
Alexion
Vertex Pharmaceuticals
After NIH trial, EMA begins rolling review for remdesivir, setting up potential authorizations in US and Europe
Endpoints
Thu, 04/30/20 - 10:43 pm
Gilead Sciences
remdesivir
COVID-19
EMA
NIH
FDA
Europe
FDA, EU authorities update guidance on clinical trials during COVID-19
RAPS.org
Tue, 04/28/20 - 11:52 pm
FDA
EMA
Europe
clinical trials
COVID-19
pandemic
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