EMA

Kite Receives Positive Opinion from CHMP for Yescarta in Lymphoma
CP Wire
Fri, 06/29/18 - 09:50 am
Kite Pharma
Gilead Sciences
EMA
CHMP
Yescarta
B-cell lymphoma
CHMP reverses course on neratinib, handing Puma an unexpected win on European marketing vote — shares soar
Endpoints
Tue, 06/26/18 - 11:58 am
Puma Biotechnology
Europe
CHMP
EMA
neratinib
Nerlynx
breast cancer
Pfizer's PARP Inhibitor Talazoparib Gets FDA Priority Review and EMA Submission
CP Wire
Thu, 06/7/18 - 12:07 pm
Pfizer
talazoparib
BRCA-mutant breast cancer
breast cancer
metastatic breast cancer
FDA
EMA
priority review
Pfizer Receives Good News for Trazimera (trastuzumab) Biosimilar
CP Wire
Fri, 06/1/18 - 10:10 am
Pfizer
CHMP
Europe
EMA
Trazimera
trastuzumab
biosimilars
Herceptin
Regulators flag possible birth defect link to GSK's HIV drug
Yahoo/Reuters
Fri, 05/18/18 - 09:27 pm
GSK
HIV
Dolutegravir
birth defects
EMA
FDA
EMA Validates Bristol-Myers Squibb’s Variation Application for Opdivo Plus Yervoy Combination for Treatment of First-Line Metastatic Non-Small Cell Lung Cancer
CP Wire
Thu, 05/3/18 - 11:16 am
Bristol-Myers Squibb
Opdivo
Yervoy
metastatic non-small cell lung cancer
EMA
Europe
AbbVie Submits Marketing Application to the European Medicines Agency for Risankizumab in Plaque Psoriasis
CP Wire
Tue, 05/1/18 - 09:25 pm
AbbVie
EMA
Europe
risankizumab
psoriasis
EU Advisory Group Backs Orphan Drug Designation for Alnylam's ALN-TTRsc02 for ATTR Amyloidosis
CP Wire
Mon, 04/23/18 - 11:01 am
Alnylam
EMA
orphan drugs
ALN-TTRsc02
ATTR amyloidosis
Amgen and Allergan Hopeful that Herceptin Biosimilar Approval Will Be Around the Corner
Xtalks
Mon, 03/26/18 - 09:36 am
Amgen
Allergan
Herceptin
biosimilars
ABP 980
CHMP
EMA
Roche
EMA’s CHMP Rejects Two Drugs Approved by US FDA in 2017
RAPS.org
Fri, 03/23/18 - 10:10 am
EMA
Europe
CHMP
FDA
Bevyxxa
Portola Pharmaceuticals
Dexxience
Tymlos
Radius Health
Eladynos
FDA Approves Drugs Before EMA and Swissmedic, Comparison Finds
RAPS.org
Sun, 02/25/18 - 11:23 am
FDA
EMA
Swissmedica
drug approvals
Europe
Switzerland
Novartis Expects FDA and EMA Approvals for Aimovig in 2018
Yahoo/Market Realist
Wed, 02/21/18 - 09:47 am
Novartis
FDA
EMA
drug approvals
Aimovig
migraines
GSK's shingles vaccine gets green light from EMA panel
Reuters
Sun, 01/28/18 - 10:04 am
GSK
EMA
Europe
shingles
vaccines
Shingrix
EMA frets drug shortages ahead of Brexit
Biopharma Dive
Wed, 01/24/18 - 08:16 pm
EMA
Europe
UK
drug shortages
Brexit
EMA investigates Allergan blockbuster hopeful Esmya on reports of liver damage
Fierce Pharma
Mon, 12/4/17 - 09:32 pm
EMA
Allergan
Esmya
Europe
uterine fibroids
FDA, EMA and PMDA Plot Harmonized Path for Antibiotics
RAPS.org
Sat, 11/18/17 - 09:46 am
FDA
EMA
PMDA
antibioitics
Europe
Japan
Aftermath of Brexit Could Cripple EMA
Xtalks
Thu, 09/28/17 - 06:23 pm
Europe
EMA
Brexit
Samsung Bioepis first to secure EMA backing for Herceptin biosimilar
BioPharma Dive
Mon, 09/18/17 - 09:23 am
Samsung Bioepis
EMA
Europe
biosimilars
Herceptin
Roche
breast cancer
Vertex's Cystic Fibrosis Combo Gets Priority Review in U.S.
Yahoo/Zacks.com
Sat, 08/26/17 - 07:41 pm
Vertex Pharmaceuticals
cystic fibrosis
FDA
priority review
EMA
tezacaftor/ivacaftor
Kalydeco
EMA and FDA will now share trade secrets, allowing both regulators to act on each other’s inspection reports
Endpoints
Thu, 08/24/17 - 11:38 am
FDA
EMA
Europe
trade secrets

Pages