You are here

EMA

EMA Restricts Use of Biogen MS Drug

EMA Restricts Use of Biogen MS Drug

RAPS.org

multiple sclerosis

Flag link:

Novo Nordisk files to add Lantus-matching CV data to Tresiba's European label

Novo Nordisk files to add Lantus-matching CV data to Tresiba's European label

Fierce Pharma

Flag link:

EMA recommends 11 drugs for approval in May meeting

EMA recommends 11 drugs for approval in May meeting

BioPharma Dive

Flag link:

Sanofi’s insulin biosimilar wins EMA committee recommendation

Sanofi’s insulin biosimilar wins EMA committee recommendation

Drug Delivery Business News

Flag link:

EU drugmakers urge June decision on new location for watchdog

EU drugmakers urge June decision on new location for watchdog

Yahoo/Reuters

Flag link:

EMA panel recommends nod for Sanofi, Regeneron's arthritis drug

EMA panel recommends nod for Sanofi, Regeneron's arthritis drug

Yahoo/Reuters

rheumatoid arthritis

Flag link:

Boehringer Ingelheim's Humira Biosimilar Under Review by EMA, FDA

Boehringer Ingelheim's Humira Biosimilar Under Review by EMA, FDA

Yahoo/GuruFocus

Boehringer Ingelheim

Flag link:

Bristol-Myers Squibb Reveals Regulatory Approvals For Opdivo Marketing Application

Bristol-Myers Squibb Reveals Regulatory Approvals For Opdivo Marketing Application

Yahoo/Benzinga

Bristol-Myers Squibb

squamous cell carcinoma of the head and neck

Flag link:

EMA removes warning from Pfizer smoking cessation drug

EMA removes warning from Pfizer smoking cessation drug

BioPharma Dive

smoking cessation

Flag link:

EMA chief: Faster drug approvals can quell Rx sticker shock

EMA chief: Faster drug approvals can quell Rx sticker shock

BioPharma Dive

Flag link:

EMA Recommends Hundreds of Drugs to be Suspended Over ‘Flawed Studies’

EMA Recommends Hundreds of Drugs to be Suspended Over ‘Flawed Studies’

WSJ Pharmalot

Flag link:

Should FDA and EMA Team up to Approve Drugs on a Reciprocal Basis?

Should FDA and EMA Team up to Approve Drugs on a Reciprocal Basis?

Regulatory Focus

Flag link:

EMA Bests FDA in 2013 New Drug Approval Numbers

EMA Bests FDA in 2013 New Drug Approval Numbers

Fierce Biotech

Flag link:

European Drug Agency Delays Trial-Data Policy Until March

European Drug Agency Delays Trial-Data Policy Until March

Bloomberg

clinical trial data

Flag link:

Pharma Blasts EMA Draft Policy On Disclosing Clinical Trial Data

Pharma Blasts EMA Draft Policy On Disclosing Clinical Trial Data

Pharmalot

clinical trial data

clinical trials

Flag link:

Simultaneous Applications Submitted to EMA and FDA for Siltuximab for the Treatment of Multicentric Castleman Disease, a Rare Blood Disorder

Simultaneous Applications Submitted to EMA and FDA for Siltuximab for the Treatment of Multicentric Castleman Disease, a Rare Blood Disorder

Reuters

multicentric Castleman disease

Flag link:

AbbVie seeks to stop EU agency releasing drug data

AbbVie seeks to stop EU agency releasing drug data

Reuters

Flag link:

Novartis gets EMA nod for Jetrea

Novartis gets EMA nod for Jetrea

FiercePharma

Flag link:

Assessing Innovative Specialized Models for Pediatrics and Neonatal Patients

Pharmacokinetics

Pharmacodynamics

Clinical Pharmacology

Flag link: