EMA

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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
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
Flag link:
Biogen's ALS Drug Tofersen Filing Accepted in Europe
Biogen's ALS Drug Tofersen Filing Accepted in Europe
Zacks.com
Biogen
ALS
EMA
Europe
tofersen
Flag link:
Pfizer/BioNTech, Moderna COVID vaccines backed for full approval in EU by EMA panel
Pfizer/BioNTech, Moderna COVID vaccines backed for full approval in EU by EMA panel
Seeking Alpha
Pfizer
BioNTech
Moderna Therapeutics
EMA
CHMP
vaccines
COVID-19
Europe
Flag link:

Pages