You are here

EMA

When Can RWE Translate Into Credible Evidence? EMA Officials Discuss

When Can RWE Translate Into Credible Evidence? EMA Officials Discuss

RAPS.org

real world evidence

real world data

Flag link:

Study: How Dependable Are Surrogate Endpoints?

Study: How Dependable Are Surrogate Endpoints?

Xtalks

clinical trials

surrogate endpoints

Flag link:

EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing?

EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing?

RAPS.org

Flag link:

Following EMA, FDA restricts use of high-dose Xeljanz, warning of added risks for the blockbuster JAK

Following EMA, FDA restricts use of high-dose Xeljanz, warning of added risks for the blockbuster JAK

Endpoints

Flag link:

Amgen/UCB hit another Evenity hurdle, as European regulators fail to back the osteoporosis drug

Amgen/UCB hit another Evenity hurdle, as European regulators fail to back the osteoporosis drug

Endpoints

Flag link:

Celgene can breathe a sigh of relief as FDA accepts once-spurned ozanimod application — setting a target date on a blockbuster decision

Celgene can breathe a sigh of relief as FDA accepts once-spurned ozanimod application — setting a target date on a blockbuster decision

Endpoints

multiple sclerosis

Flag link:

Bluebird Bio’s Gene Therapy for Blood Disease Wins European Approval

Bluebird Bio’s Gene Therapy for Blood Disease Wins European Approval

Xconomy

beta thalassemia

Flag link:

EMA imposes formal limit on Xeljanz prescription as regulators continue to review safety concerns

EMA imposes formal limit on Xeljanz prescription as regulators continue to review safety concerns

Endpoints

post-marketing studies

Flag link:

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

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

Flag link:

Drug Sampling and Testing: EMA Releases 20 Year Report, Will Expand Program to Biosimilars

Drug Sampling and Testing: EMA Releases 20 Year Report, Will Expand Program to Biosimilars

RAPS.org

Flag link:

Aimmune's peanut allergy immunotherapy clears European PhIII with flying colors, paving way for first US, EU therapeutic approval

Aimmune's peanut allergy immunotherapy clears European PhIII with flying colors, paving way for first US, EU therapeutic approval

Endpoints

Flag link:

EMA sounds its own safety alarm for Pfizer blockbuster, but they’re also not forcing a limit on dosing — yet

EMA sounds its own safety alarm for Pfizer blockbuster, but they’re also not forcing a limit on dosing — yet

Endpoints

rheumatoid arthritis

Flag link:

Merck Gets CHMP Nod for Six-Week Dosing Option of Keytruda

Merck Gets CHMP Nod for Six-Week Dosing Option of Keytruda

Yahoo/Zacks.com

Flag link:

Sanofi's isatuximab meets survival endpoint for third-line multiple myeloma

Sanofi's isatuximab meets survival endpoint for third-line multiple myeloma

BioCentury

relapsed or refractory multiple myeloma

Multiple Myeloma

Flag link:

AstraZeneca’s Forxiga recommended for marketing authorization in EU

AstraZeneca’s Forxiga recommended for marketing authorization in EU

Pharmaceutical Business Review

type 1 diabetes

Flag link:

In another setback for Eli Lilly, FDA follows EMA in calling for a halt to new Lartruvo prescriptions

In another setback for Eli Lilly, FDA follows EMA in calling for a halt to new Lartruvo prescriptions

Endpoints

Flag link:

As Brexit nears, EMA improves staff retention forecast, commits to uninterrupted drug evaluations

As Brexit nears, EMA improves staff retention forecast, commits to uninterrupted drug evaluations

Fierce Biotech

Flag link:

How Pharmaceuticals Impact the Environment: EMA Revises Guideline

How Pharmaceuticals Impact the Environment: EMA Revises Guideline

RAPS.org

environmental concerns

Flag link:

FDA to Follow EMA With Move From London to Amsterdam

FDA to Follow EMA With Move From London to Amsterdam

RAPS.org

Flag link:

Sanofi teams with non-profit on a landmark new drug for sleeping sickness

Sanofi teams with non-profit on a landmark new drug for sleeping sickness

Endpoints

sleeping sickness

Flag link:

Pages