You are here

EMA

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:

FDA, EMA delay review of Opdivo/Yervoy for first-line NSCLC

FDA, EMA delay review of Opdivo/Yervoy for first-line NSCLC

BioCentury

Bristol-Myers Squibb

non-small cell lung cancer

Flag link:

Shire's drug for rare swelling disorder wins European panel green light

Shire's drug for rare swelling disorder wins European panel green light

Reuters

Flag link:

EMA Accepts Bluebird Bio's Marketing Authorization Application for Gene Therapy for Rare Blood Disorder

EMA Accepts Bluebird Bio's Marketing Authorization Application for Gene Therapy for Rare Blood Disorder

CP Wire

transfusion-dependent anemia

Flag link:

Pfizer responds to FDA, EMA and Canada after reinspections of plant that makes injected painkillers

Pfizer responds to FDA, EMA and Canada after reinspections of plant that makes injected painkillers

Fierce Pharma

drug manufacturing

Flag link:

Roche gets some regulatory love for its breakthrough quest on a PhIII Huntington’s drug

Roche gets some regulatory love for its breakthrough quest on a PhIII Huntington’s drug

Endpoints

Huntington's disease

Flag link:

Brexit forces EMA to suspend tasks as job loss forecast jumps

Brexit forces EMA to suspend tasks as job loss forecast jumps

Fierce Biotech

Flag link:

Bluebird’s first gene therapy gets European fast track

Bluebird’s first gene therapy gets European fast track

PM Live

Flag link:

Alnylam Receives Positive CHMP Opinion for Hereditary Amyloidosis Treatment

Alnylam Receives Positive CHMP Opinion for Hereditary Amyloidosis Treatment

CP Wire

hATTR amyloidosis

Flag link:

Pages