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EMA

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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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

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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

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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

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Brexit forces EMA to suspend tasks as job loss forecast jumps

Brexit forces EMA to suspend tasks as job loss forecast jumps

Fierce Biotech

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Bluebird’s first gene therapy gets European fast track

Bluebird’s first gene therapy gets European fast track

PM Live

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Alnylam Receives Positive CHMP Opinion for Hereditary Amyloidosis Treatment

Alnylam Receives Positive CHMP Opinion for Hereditary Amyloidosis Treatment

CP Wire

hATTR amyloidosis

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Regulators recall valsartan after finding impurity tied to cancer risk

Regulators recall valsartan after finding impurity tied to cancer risk

Biopharma Dive

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

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

CP Wire

Boehringer Ingelheim

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Kite Receives Positive Opinion from CHMP for Yescarta in Lymphoma

Kite Receives Positive Opinion from CHMP for Yescarta in Lymphoma

CP Wire

Gilead Sciences

B-cell lymphoma

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CHMP reverses course on neratinib, handing Puma an unexpected win on European marketing vote — shares soar

CHMP reverses course on neratinib, handing Puma an unexpected win on European marketing vote — shares soar

Endpoints

Puma Biotechnology

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Pfizer's PARP Inhibitor Talazoparib Gets FDA Priority Review and EMA Submission

Pfizer's PARP Inhibitor Talazoparib Gets FDA Priority Review and EMA Submission

CP Wire

BRCA-mutant breast cancer

metastatic breast cancer

priority review

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