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EMA

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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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AstraZeneca’s Forxiga recommended for marketing authorization in EU

AstraZeneca’s Forxiga recommended for marketing authorization in EU

Pharmaceutical Business Review

type 1 diabetes

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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

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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

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How Pharmaceuticals Impact the Environment: EMA Revises Guideline

How Pharmaceuticals Impact the Environment: EMA Revises Guideline

RAPS.org

environmental concerns

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FDA to Follow EMA With Move From London to Amsterdam

FDA to Follow EMA With Move From London to Amsterdam

RAPS.org

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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

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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

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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

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