EMA

EMA validates Pfizer and OPKO’s somatrogon marketing application for review
EMA validates Pfizer and OPKO’s somatrogon marketing application for review
Pharmaceutical Business Review
Pfizer
OPKO Health
EMA
Europe
somatrogon
HGH
growth hormone deficiency
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Janssen's COVID vaccine application submitted to EMA
Janssen's COVID vaccine application submitted to EMA
RAPS.org
JNJ
Janssen
EMA
Europe
vaccines
COVID-19
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CureVac's COVID vaccine enters EMA's rolling review
CureVac's COVID vaccine enters EMA's rolling review
RAPS.org
CureVac
EMA
Europe
vaccines
COVID-19
CVnCoV
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The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA
The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA
Drug Patent Watch
regulatory
biosimilars
Europe
EMA
FDA
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Janssen flags accelerated approval milestone in Europe for CAR-T therapy
Janssen flags accelerated approval milestone in Europe for CAR-T therapy
Biopharma Reporter
JNJ
Janssen
CAR-T
EMA
Europe
cilta-cel
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Cyberattack: EMA says leaked documents ‘manipulated’
Cyberattack: EMA says leaked documents ‘manipulated’
RAPS.org
COVID-19
vaccines
EMA
cyberattack
cybersecurity
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Hackers steal Pfizer, BioNTech data in EMA breach as cybersecurity attacks heat up
Hackers steal Pfizer, BioNTech data in EMA breach as cybersecurity attacks heat up
Endpoints
cybersecurity
data breach
cyberattack
hackers
vaccines
EMA
Pfizer
BioNTech
COVID-19
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Janssen combines Darzalex with COVID-19 drug in new multiple myeloma submission
Janssen combines Darzalex with COVID-19 drug in new multiple myeloma submission
Pharmaforum
Janssen
Multiple Myeloma
Darzalex
EMA
FDA
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Why DBV Technologies Stock Is Soaring Today
Why DBV Technologies Stock Is Soaring Today
Motley Fool
DBV Technologies
Viaskin Peanut
peanut allergy
Europe
EMA
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Study: Few new drugs have high therapeutic value
Study: Few new drugs have high therapeutic value
RAPS.org
British Medical Journal
FDA
EMA
therapeutic value
drug approvals
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Thinking the unthinkable on Covid vaccine approvals
Thinking the unthinkable on Covid vaccine approvals
EP Vantage
COVID-19
pandemic
regulatory
FDA
EMA
Europe
vaccines
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European Medicines Agency reviewing reports of kidney injury in patients taking Gilead's remdesivir
European Medicines Agency reviewing reports of kidney injury in patients taking Gilead's remdesivir
Beckers Hospital Review
EMA
Europe
Gilead Sciences
remdesivir
COVID-19
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Takeda takes a $200M hit after Novartis is forced to yank its marketing application for Xiidra
Takeda takes a $200M hit after Novartis is forced to yank its marketing application for Xiidra
Endpoints
Takeda
Novartis
Xiidra
Europe
EMA
dry eye disease
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Vertex : CHMP Grants Positive Opinion For KAFTRIO - KALYDECO In People Ages 12 And Older With CF
Vertex : CHMP Grants Positive Opinion For KAFTRIO - KALYDECO In People Ages 12 And Older With CF
Business Insider
Vertex Pharmaceuticals
Europe
EMA
CHMP
cystic fibrosis
Kalydeco
Kaftrio
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COVID-19 drug remdesivir recommended for EU approval
COVID-19 drug remdesivir recommended for EU approval
Pharmaforum
Gilead
remdesivir
EMA
Europe
CHMP
COVID-19
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Regulators discuss accelerated approvals, Project Orbis at DIA
Regulators discuss accelerated approvals, Project Orbis at DIA
RAPS.org
regulatory
DIA
accelerated approvals
FDA
EMA
Health Canada
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Drug regulators in agreement on coronavirus vaccine trials, FDA official says
Drug regulators in agreement on coronavirus vaccine trials, FDA official says
BioPharma Dive
vaccines
pandemic
COVID-19
FDA
Health Canada
EMA
clinical trials
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Gilead files remdesivir for EU approval, with a verdict possible “in weeks”
Gilead files remdesivir for EU approval, with a verdict possible “in weeks”
Pharmaforum
EMA
Europe
Gilead Sciences
remdesivir
COVID-19
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EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication
EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication
RAPS.org
EMA
Europe
regulatory
clinical trial transparency
COVID-19
pandemic
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EMA extends virtual-only meeting policy through August
EMA extends virtual-only meeting policy through August
Endpoints
EMA
Europe
FDA
COVID-19
pandemic
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