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Home
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companies
» EMA
EMA
EMA details new drug supply monitoring system for COVID-19
RAPS.org
Wed, 04/22/20 - 12:02 am
EMA
Europe
COVID-19
fast track
BMS' Opdivo gets another lung cancer shot as FDA, EMA accept chemo combo filings
Fierce Pharma
Wed, 04/8/20 - 11:40 pm
Bristol-Myers Squibb
Opdivo
Yervoy
non-small cell lung cancer
FDA
Europe
priority review
EMA
EMA clears compassionate use of Gilead’s remdesivir for COVID-19
Pharmaforum
Tue, 04/7/20 - 07:42 pm
Europe
EMA
Gilead Sciences
COVID-19
remdesivir
GSK, Innoviva seek EMA approval for Trelegy Ellipta to treat asthma in adults
Pharmaceutical Business Review
Fri, 02/28/20 - 10:30 am
GSK
Innoviva
EMA
Europe
asthma
Trelegy Elipta
Dutch biotech sector feel benefits of EMA move, says industry leader
Pharmaforum
Tue, 02/4/20 - 10:07 am
EMA
Europe
The Netherlands
Brexit
biotech
Janssen seeks EMA nod for Imbruvica, rituximab combo in previously untreated CLL
Pharmaceutical Business Review
Mon, 01/20/20 - 10:57 am
Janssen
JNJ
EMA
Imbruvica
CLL
With EMA review in progress, Novartis unveils more positive data on asthma therapy
Endpoints
Fri, 12/6/19 - 10:27 am
Novartis
EMA
asthma
QMF149
clinical trials
Pfizer's Xeljanz gets EMA blood clots warning following FDA's similar move
Fierce Pharma
Sat, 11/16/19 - 10:27 pm
Europe
EMA
ulcerative colitis
Pfizer
Xeljanz
Five drugs, including two Novartis therapies, win EMA endorsement
Endpoints
Fri, 11/15/19 - 12:22 pm
EMA
Europe
Novartis
Mayzent
Isturisa
Roche
Polivy
Jazz Pharma
Sunosi
Rigel Pharma
Tavlesse
CHMP backs world’s first Ebola vaccine from Merck, NewLink
Pharmaforum
Mon, 10/21/19 - 10:13 am
Merck
ebola virus
vaccines
CHMP
EMA
Europe
NewLink Genetics
When Can RWE Translate Into Credible Evidence? EMA Officials Discuss
RAPS.org
Wed, 10/2/19 - 07:36 pm
RWE
real world evidence
real world data
EMA
Study: How Dependable Are Surrogate Endpoints?
Xtalks
Fri, 09/13/19 - 10:42 am
FDA
EMA
clinical trials
surrogate endpoints
EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing?
RAPS.org
Fri, 08/16/19 - 12:57 pm
FDA
EMA
Europe
drug approvals
Following EMA, FDA restricts use of high-dose Xeljanz, warning of added risks for the blockbuster JAK
Endpoints
Fri, 07/26/19 - 11:14 am
FDA
Pfizer
Xeljanz
warning
EMA
Amgen/UCB hit another Evenity hurdle, as European regulators fail to back the osteoporosis drug
Endpoints
Fri, 06/28/19 - 10:04 am
Amgen
UCB Pharma
FDA
EMA
Europe
osteoporosis
Evenity
romosozumab
Celgene can breathe a sigh of relief as FDA accepts once-spurned ozanimod application — setting a target date on a blockbuster decision
Endpoints
Thu, 06/6/19 - 09:53 am
Celgene
FDA
EMA
ozanimod
multiple sclerosis
Bluebird Bio’s Gene Therapy for Blood Disease Wins European Approval
Xconomy
Mon, 06/3/19 - 07:50 pm
Bluebird Bio
gene therapy
Europe
Zynteglo
EMA
beta thalassemia
EMA imposes formal limit on Xeljanz prescription as regulators continue to review safety concerns
Endpoints
Sat, 05/18/19 - 08:47 pm
EMA
Pfizer
Europe
Xeljanz
post-marketing studies
After falling short on prelim OS data, EMA tells Aveo it wants to see something better on its long suffering tivo this summer — or else
Endpoints
Wed, 04/3/19 - 10:03 am
Aveo Oncology
tivozanib
EMA
Europe
Drug Sampling and Testing: EMA Releases 20 Year Report, Will Expand Program to Biosimilars
RAPS.org
Thu, 03/28/19 - 07:45 pm
EMA
Europe
biosimilars
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