EMA

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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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
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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
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BioMarin's hemophilia gene therapy Roctavian wins conditional EU backing amid FDA delay
BioMarin's hemophilia gene therapy Roctavian wins conditional EU backing amid FDA delay
Fierce Pharma
Biomarin
Roctavian
EMA
FDA
hemophilia A
valoctocogene roxaparvovec
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More drug, fewer jabs: Novartis' Sandoz eyes EMA nod for high-concentration Humira copy
More drug, fewer jabs: Novartis' Sandoz eyes EMA nod for high-concentration Humira copy
Fierce Pharma
Novartis
Sandoz
AbbVie
Humira
Europe
biosimilars
autoimmune disease
EMA
Hyrimoz
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Pfizer (PFE) Starts EU Submission of Variant-Adapted Vaccine
Pfizer (PFE) Starts EU Submission of Variant-Adapted Vaccine
Yahoo/Zacks.com
Pfizer
BioNTech
Europe
EMA
COVID-19
COVID variant-adapted vaccine
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EHA: ADC preps filings for Hodgkin lymphoma drug after ph2 readout
EHA: ADC preps filings for Hodgkin lymphoma drug after ph2 readout
Pharmaforum
ADC Therapeutics
antibody-drug conjugate
camidanlumab tesirine
EMA
relapsed or refractory Hodgkins lymphoma
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Study: FDA approves new oncology drugs quicker than EMA
Study: FDA approves new oncology drugs quicker than EMA
RAPS.org
JAMA
regulatory
drug approvals
FDA
EMA
Europe
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AstraZeneca (AZN) Gets EU Nod for COVID-19 Booster Shot
AstraZeneca (AZN) Gets EU Nod for COVID-19 Booster Shot
Yahoo/Zacks.com
AstraZeneca
Europe
EMA
vaccines
COVID-19
boosters
Vaxzevria
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EMA shortens timeline for Moderna's Spikevax Covid booster 
EMA shortens timeline for Moderna's Spikevax Covid booster 
Endpoints
Moderna Therapeutics
EMA
COVID-19
vaccines
boosters
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EMA sets out plan to accelerate clinical trials, reduce administrative burden
EMA sets out plan to accelerate clinical trials, reduce administrative burden
Fierce Biotech
EMA
Europe
clinical trials
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AbbVie seeks approval for upadacitinib to treat nr-axSpA
AbbVie seeks approval for upadacitinib to treat nr-axSpA
Pharmaceutical Business Review
AbbVie
FDA
EMA
upadacatinib
nr-axSpA
non-radiographic axial spondyloarthritis
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As Omicron cases rise, EMA backs early use of Pfizer’s Paxlovid
As Omicron cases rise, EMA backs early use of Pfizer’s Paxlovid
Pharmaforum
Pfizer
Paxlovid
EMA
Europe
COVID-19
Omicron COVID-19 variant
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AbbVie seeks EMA approval for risankizumab (Skyrizi) to treat moderate to severe Crohn’s disease
AbbVie seeks EMA approval for risankizumab (Skyrizi) to treat moderate to severe Crohn’s disease
Pharmaceutical Business Review
AbbVie
Europe
EMA
Skyrizi
Crohn’s disease
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