EMA

Europe recommends the approval of Pfizer’s RSV vaccine for older adults and in pregnancy
Stat
Fri, 07/21/23 - 10:13 am
Pfizer
vaccines
RSV
pregnancy
elderly
Europe
EMA
Astellas' Zolbetuximab Is a Promising Therapy for HER2-Negative Gastric Cancer
Xtalks
Mon, 07/17/23 - 06:54 pm
Astellas
zolbetuximab
gastric cancer
FDA
EMA
European regulators probe suicide risk to Ozempic, other Novo drug Saxenda
BioPharma Dive
Mon, 07/10/23 - 09:40 pm
Novo Nordisk
Ozempic
Saxenda
EMA
Europe
suicide
Ipsen and Genfit to file for EMA and FDA approval for elafibranor
Clinical Trials Arena
Fri, 06/30/23 - 10:12 am
Ipsen
Genfit
EMA
FDA
elafibranor
liver disease
primary biliary cholangitis
GSK’s daprodustat obtains positive opinion from EMA CHMP
Pharmaceutical Business Review
Tue, 06/27/23 - 10:12 am
EMA
Europe
GSK
CHMP
daprodustat
chronic kidney disease
EMA's Advisory Panel Gives Thumbs Down To Amylyx Pharma's ALS Treatment
Benzinga
Fri, 06/23/23 - 09:51 am
Amylyx Pharmaceuticals
ALS
Albrioza
EMA
Europe
Novo Nordisk says EMA raised safety signal on drugs including semaglutide
Yahoo/Reuters
Thu, 06/22/23 - 10:21 am
Novo Nordisk
EMA
semaglutide
Ozempic
Wegovy
thyroid cancer
obesity
diabetes
Amylyx’s ALS drug could face rejection in Europe
BioPharma Dive
Wed, 05/31/23 - 10:45 am
Amylyx
ALS
EMA
Europe
Relyvrio
EMA Panel Endorses Novavax's (NVAX) COVID vaccine for Full Approval
Yahoo/Zacks.com
Tue, 05/30/23 - 09:52 am
Novavax
EMA
Europe
vaccines
CHMP
COVID-19
Pharma fees to European regulator spike thanks to 10% inflation rate
Endpoints
Tue, 04/4/23 - 11:23 am
EMA
Europe
inflation
CHMP gives thumbs-up for Wegovy use in adolescents, along with nine new drug recommendations
Endpoints
Sun, 04/2/23 - 04:17 pm
EMA
Europe
CHMP
Wegovy
Novo Nordisk
Bimervax
TG Therapeutics
Eli Lilly
Bristol Myers Squibb
Novartis
AstraZeneca
Biogen gets EU court ruling in favor of blocking Tecfidera generic entry
Seeking Alpha
Thu, 03/16/23 - 09:44 am
Biogen
EMA
Europe
MS
multiple sclerosis
Tecfidera
generics
Merck asks EMA to reevaluate rejected Covid-19 antiviral
Endpoints
Mon, 03/13/23 - 04:40 pm
Merck
Europe
EMA
COVID-19
Lagevrio
molnupiravir
antivirals
EMA validates Vertex's CRISPR application, clearing barrier on road to landmark approval
Fierce Biotech
Thu, 01/26/23 - 10:53 am
Vertex Pharmaceuticals
CRISPR Therapeutics
EMA
CRISPR
sickle cell disease
exa-cel
Biogen's ALS Drug Tofersen Filing Accepted in Europe
Zacks.com
Tue, 12/6/22 - 10:48 am
Biogen
ALS
EMA
Europe
tofersen
Pfizer/BioNTech, Moderna COVID vaccines backed for full approval in EU by EMA panel
Seeking Alpha
Fri, 09/16/22 - 10:49 am
Pfizer
BioNTech
Moderna Therapeutics
EMA
CHMP
vaccines
COVID-19
Europe
BioMarin's hemophilia gene therapy Roctavian wins conditional EU backing amid FDA delay
Fierce Pharma
Mon, 06/27/22 - 10:05 am
Biomarin
Roctavian
EMA
FDA
hemophilia A
valoctocogene roxaparvovec
More drug, fewer jabs: Novartis' Sandoz eyes EMA nod for high-concentration Humira copy
Fierce Pharma
Mon, 06/20/22 - 10:37 am
Novartis
Sandoz
AbbVie
Humira
Europe
biosimilars
autoimmune disease
EMA
Hyrimoz
Pfizer (PFE) Starts EU Submission of Variant-Adapted Vaccine
Yahoo/Zacks.com
Thu, 06/16/22 - 10:33 am
Pfizer
BioNTech
Europe
EMA
COVID-19
COVID variant-adapted vaccine
EHA: ADC preps filings for Hodgkin lymphoma drug after ph2 readout
Pharmaforum
Mon, 06/13/22 - 10:46 am
ADC Therapeutics
antibody-drug conjugate
camidanlumab tesirine
EMA
relapsed or refractory Hodgkins lymphoma

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