EMA

European regulator endorses high-dose version of Bayer eye drug Eylea
European regulator endorses high-dose version of Bayer eye drug Eylea
Reuters
Bayer
EMA
Eylea
Roche
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Santhera closes on first approval for DMD drug vamorolone
Santhera closes on first approval for DMD drug vamorolone
Pharmaphorum
Santhera
Duchenne Muscular Dystrophy
DMD
vamorolone
EMA
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Europe expects to decide on Novavax's COVID vaccine in October
Europe expects to decide on Novavax's COVID vaccine in October
Reuters
Europe
EMA
Novavax
vaccines
COVID-19
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EU clears review of Xtandi in earlier-stage prostate cancer
EU clears review of Xtandi in earlier-stage prostate cancer
Pharmaphorum
EMA
Europe
Astellas
Pfizer
prostate cancer
Xtandi
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Novartis sickle cell drug’s approval formally revoked by EU regulators
Novartis sickle cell drug’s approval formally revoked by EU regulators
BioPharma Dive
Novartis
Adakveo
sickle cell disease
Europe
EMA
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Controlling the pharma machine: EMA conveys thoughts on AI use in industry
Controlling the pharma machine: EMA conveys thoughts on AI use in industry
Clinical Trials Arena
EMA
Europe
artificial intelligence
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Europe recommends the approval of Pfizer’s RSV vaccine for older adults and in pregnancy
Europe recommends the approval of Pfizer’s RSV vaccine for older adults and in pregnancy
Stat
Pfizer
vaccines
RSV
pregnancy
elderly
Europe
EMA
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Astellas' Zolbetuximab Is a Promising Therapy for HER2-Negative Gastric Cancer
Astellas' Zolbetuximab Is a Promising Therapy for HER2-Negative Gastric Cancer
Xtalks
Astellas
zolbetuximab
gastric cancer
FDA
EMA
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European regulators probe suicide risk to Ozempic, other Novo drug Saxenda
European regulators probe suicide risk to Ozempic, other Novo drug Saxenda
BioPharma Dive
Novo Nordisk
Ozempic
Saxenda
EMA
Europe
suicide
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Ipsen and Genfit to file for EMA and FDA approval for elafibranor
Ipsen and Genfit to file for EMA and FDA approval for elafibranor
Clinical Trials Arena
Ipsen
Genfit
EMA
FDA
elafibranor
liver disease
primary biliary cholangitis
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GSK’s daprodustat obtains positive opinion from EMA CHMP
GSK’s daprodustat obtains positive opinion from EMA CHMP
Pharmaceutical Business Review
EMA
Europe
GSK
CHMP
daprodustat
chronic kidney disease
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EMA's Advisory Panel Gives Thumbs Down To Amylyx Pharma's ALS Treatment
EMA's Advisory Panel Gives Thumbs Down To Amylyx Pharma's ALS Treatment
Benzinga
Amylyx Pharmaceuticals
ALS
Albrioza
EMA
Europe
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Novo Nordisk says EMA raised safety signal on drugs including semaglutide
Novo Nordisk says EMA raised safety signal on drugs including semaglutide
Yahoo/Reuters
Novo Nordisk
EMA
semaglutide
Ozempic
Wegovy
thyroid cancer
obesity
diabetes
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Amylyx’s ALS drug could face rejection in Europe
Amylyx’s ALS drug could face rejection in Europe
BioPharma Dive
Amylyx
ALS
EMA
Europe
Relyvrio
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EMA Panel Endorses Novavax's (NVAX) COVID vaccine for Full Approval
EMA Panel Endorses Novavax's (NVAX) COVID vaccine for Full Approval
Yahoo/Zacks.com
Novavax
EMA
Europe
vaccines
CHMP
COVID-19
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Pharma fees to European regulator spike thanks to 10% inflation rate
Pharma fees to European regulator spike thanks to 10% inflation rate
Endpoints
EMA
Europe
inflation
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CHMP gives thumbs-up for Wegovy use in adolescents, along with nine new drug recommendations
CHMP gives thumbs-up for Wegovy use in adolescents, along with nine new drug recommendations
Endpoints
EMA
Europe
CHMP
Wegovy
Novo Nordisk
Bimervax
TG Therapeutics
Eli Lilly
Bristol Myers Squibb
Novartis
AstraZeneca
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Biogen gets EU court ruling in favor of blocking Tecfidera generic entry
Biogen gets EU court ruling in favor of blocking Tecfidera generic entry
Seeking Alpha
Biogen
EMA
Europe
MS
multiple sclerosis
Tecfidera
generics
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Merck asks EMA to reevaluate rejected Covid-19 antiviral
Merck asks EMA to reevaluate rejected Covid-19 antiviral
Endpoints
Merck
Europe
EMA
COVID-19
Lagevrio
molnupiravir
antivirals
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EMA validates Vertex's CRISPR application, clearing barrier on road to landmark approval
EMA validates Vertex's CRISPR application, clearing barrier on road to landmark approval
Fierce Biotech
Vertex Pharmaceuticals
CRISPR Therapeutics
EMA
CRISPR
sickle cell disease
exa-cel
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