EMA

PTC Therapeutics Faces Setback on Translarna Approval
Tip Ranks
Fri, 10/18/24 - 11:31 am
PTC Therapeutics
EMA
Europe
Translarna
Duchenne Muscular Dystrophy
EMA concerned about MAA delays, working on solutions
RAPS.org
Wed, 10/2/24 - 09:53 pm
EMA
Europe
drug approvals
EU regulator backs use of Novo's Wegovy for obesity-related heart condition
Reuters
Thu, 09/19/24 - 09:16 pm
Novo Nordisk
Wegovy
obesity
EMA
Europe
heart failure with preserved ejection fraction
EU starts review of Enhertu in HER2-ultra-low breast cancer
Pharmaphorum
Mon, 08/19/24 - 09:56 am
EMA
Europe
AstraZeneca
Daiichi Sankyo
breast cancer
Enhertu
Eisai 'extremely disappointed' by EMA's decision on Alzheimer's drug
Biopharma Reporter
Tue, 07/30/24 - 11:37 am
Eisai
EMA
Europe
Leqembi
Biogen
Alzheimer's disease
AbbVie Submits Applications for Rinvoq for Giant Cell Arteritis
Managed Healthcare Executive
Sun, 07/14/24 - 10:12 pm
AbbVie
Rinvoq
FDA
EMA
giant cell arteritis
Patients on weight-loss drugs should inform doctor before surgery, EU regulator says
Reuters
Fri, 07/12/24 - 11:16 am
EMA
Novo Nordisk
Ozempic
Wegovy
Eli Lilly
Mounjaro
Zepbound
surgery
Dupixent nears EU approval for COPD, as FDA delays
Pharmaphorum
Fri, 05/31/24 - 10:49 am
Sanofi
Regeneron
Dupixent
COPD
EMA
Europe
FDA
European regulators find no evidence of link between new obesity medicines and suicidal thoughts
Stat
Fri, 04/12/24 - 11:09 am
Novo Nordisk
Ozempic
Wegovy
EMA
obesity
weight loss
suicide
EMA to Review Diabetes and Weight-Loss Drugs for Suicidal Ideation Risk
BioSpace
Tue, 04/9/24 - 11:11 am
EMA
Europe
diabetes
weight loss
Novo Nordisk
Ozempic
Wegovy
Eli Lilly
Trulicity
Saxenda
Rybelsus
Victoza
89bio wins EMA priority status for MASH candidate pegozafermin
Clinical Trials Arena
Thu, 03/28/24 - 11:21 am
89Bio
Europe
EMA
pegozafermin
MASH
EMA and FDA green-light MoonLake to advance IL-17 inhibitor
Clinical Trials Arena
Wed, 02/28/24 - 09:38 pm
MoonLake Immunotherapeutics
sonelokimab
FDA
EMA
hidradenitis suppurativa
US, EU regulators start swift reviews of Servier glioma drug
Pharmaphorum
Wed, 02/21/24 - 11:09 am
FDA
EMA
Servier
vorasidenib
glioma
brain cancer
PTC's re-examination bid for DMD drug Translarna falls short in Europe
Fierce Pharma
Fri, 01/26/24 - 11:10 am
PTC Therapeutics
EMA
Europe
Translarna
DMD
European regulator endorses high-dose version of Bayer eye drug Eylea
Reuters
Fri, 11/10/23 - 10:09 am
Bayer
EMA
Eylea
Roche
Santhera closes on first approval for DMD drug vamorolone
Pharmaphorum
Fri, 10/13/23 - 10:23 am
Santhera
Duchenne Muscular Dystrophy
DMD
vamorolone
EMA
Europe expects to decide on Novavax's COVID vaccine in October
Reuters
Thu, 09/21/23 - 10:33 am
Europe
EMA
Novavax
vaccines
COVID-19
EU clears review of Xtandi in earlier-stage prostate cancer
Pharmaphorum
Wed, 09/13/23 - 06:02 pm
EMA
Europe
Astellas
Pfizer
prostate cancer
Xtandi
Novartis sickle cell drug’s approval formally revoked by EU regulators
BioPharma Dive
Sun, 08/6/23 - 09:27 pm
Novartis
Adakveo
sickle cell disease
Europe
EMA
Controlling the pharma machine: EMA conveys thoughts on AI use in industry
Clinical Trials Arena
Sun, 07/23/23 - 12:22 pm
EMA
Europe
artificial intelligence

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