You are here

EMA

Samsung Bioepis first to secure EMA backing for Herceptin biosimilar

Samsung Bioepis first to secure EMA backing for Herceptin biosimilar

BioPharma Dive

Samsung Bioepis

Flag link:

Vertex's Cystic Fibrosis Combo Gets Priority Review in U.S.

Vertex's Cystic Fibrosis Combo Gets Priority Review in U.S.

Yahoo/Zacks.com

Vertex Pharmaceuticals

cystic fibrosis

priority review

tezacaftor/ivacaftor

Flag link:

EMA and FDA will now share trade secrets, allowing both regulators to act on each other’s inspection reports

EMA and FDA will now share trade secrets, allowing both regulators to act on each other’s inspection reports

Endpoints

Flag link:

EMA Backs Eight New Medicines, Turns Down Drugs From Nektar & Vanda

EMA Backs Eight New Medicines, Turns Down Drugs From Nektar & Vanda

RAPS.org

Lexicon Pharmaceuticals

Flag link:

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: