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» EMA
EMA
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
Study: FDA approves new oncology drugs quicker than EMA
RAPS.org
Mon, 06/13/22 - 10:33 am
JAMA
regulatory
drug approvals
FDA
EMA
Europe
AstraZeneca (AZN) Gets EU Nod for COVID-19 Booster Shot
Yahoo/Zacks.com
Wed, 05/25/22 - 10:36 am
AstraZeneca
Europe
EMA
vaccines
COVID-19
boosters
Vaxzevria
EMA shortens timeline for Moderna's Spikevax Covid booster
Endpoints
Sun, 02/27/22 - 10:19 pm
Moderna Therapeutics
EMA
COVID-19
vaccines
boosters
EMA sets out plan to accelerate clinical trials, reduce administrative burden
Fierce Biotech
Fri, 01/14/22 - 11:16 am
EMA
Europe
clinical trials
AbbVie seeks approval for upadacitinib to treat nr-axSpA
Pharmaceutical Business Review
Mon, 01/10/22 - 11:29 am
AbbVie
FDA
EMA
upadacatinib
nr-axSpA
non-radiographic axial spondyloarthritis
As Omicron cases rise, EMA backs early use of Pfizer’s Paxlovid
Pharmaforum
Fri, 12/17/21 - 11:00 am
Pfizer
Paxlovid
EMA
Europe
COVID-19
Omicron COVID-19 variant
AbbVie seeks EMA approval for risankizumab (Skyrizi) to treat moderate to severe Crohn’s disease
Pharmaceutical Business Review
Wed, 12/1/21 - 10:22 am
AbbVie
Europe
EMA
Skyrizi
Crohn’s disease
EMA starts rolling review of Merck's molnupiravir, continuing rapid regulatory response to COVID-19 antiviral data
Fierce Biotech
Mon, 10/25/21 - 10:58 am
Merck
molnupiravir
antivirals
COVID-19
Ridgeback Biotherapeutics
EMA
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