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EMA

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

Endpoints

Mon, 03/25/19 - 12:03 pm

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

Endpoints

Wed, 03/20/19 - 08:14 pm

rheumatoid arthritis

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

Yahoo/Zacks.com

Tue, 03/5/19 - 09:35 am

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

BioCentury

Tue, 02/5/19 - 10:09 am

relapsed or refractory multiple myeloma

Multiple Myeloma

AstraZeneca’s Forxiga recommended for marketing authorization in EU

Pharmaceutical Business Review

Mon, 02/4/19 - 09:52 am

type 1 diabetes

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

Endpoints

Fri, 01/25/19 - 12:12 pm

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

Fierce Biotech

Tue, 01/15/19 - 11:09 am

How Pharmaceuticals Impact the Environment: EMA Revises Guideline

RAPS.org

Sat, 12/1/18 - 11:56 am

environmental concerns

FDA to Follow EMA With Move From London to Amsterdam

RAPS.org

Thu, 11/29/18 - 07:32 pm

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

Endpoints

Fri, 11/16/18 - 12:08 pm

sleeping sickness

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

BioCentury

Sat, 10/20/18 - 11:13 pm

Bristol-Myers Squibb

non-small cell lung cancer

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

Reuters

Sat, 10/20/18 - 11:04 pm

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

CP Wire

Fri, 10/5/18 - 09:50 am

transfusion-dependent anemia

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

Fierce Pharma

Mon, 08/20/18 - 11:32 am

drug manufacturing

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

Endpoints

Fri, 08/3/18 - 11:31 pm

Huntington's disease

Brexit forces EMA to suspend tasks as job loss forecast jumps

Fierce Biotech

Thu, 08/2/18 - 10:57 am

Bluebird’s first gene therapy gets European fast track

PM Live

Sat, 07/28/18 - 12:26 pm

Alnylam Receives Positive CHMP Opinion for Hereditary Amyloidosis Treatment

CP Wire

Fri, 07/27/18 - 10:22 am

hATTR amyloidosis

Regulators recall valsartan after finding impurity tied to cancer risk

Biopharma Dive

Thu, 07/19/18 - 09:06 pm

CHMP Issues Positive Opinion to Expand Labeling of Jardiance, Synjardy and Glyxambi to Include Positive Effects on Cardiovascular and Renal Outcomes

CP Wire

Mon, 07/2/18 - 10:02 am

Boehringer Ingelheim

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