ema
Janssen makes EMA marketing application for talquetamab for RRMM
Nicole Raleigh
ASH 2022, bispecifics, ema, fda, Janssen, MAA, multiple myeloma, talquetamab
0 Comment
EMA unveils first projects as data partners join DARWIN EU project
Phil Taylor
big data, DARWIN, digital, digital health, ema, EU, real world data, Real World Evidence
0 Comment
EU regulator lifts GSK amid torrid week for company’s pipeline
Phil Taylor
cabotegravir, ema, GlaxoSmithKline, respiratory syncytial virus, vaccine
0 Comment
Takeda dengue vaccine receives positive CHMP opinion
Nicole Raleigh
CHMP, dengue, ema, mosquitoes, Qdenga, regulatory, TAK-003, Takeda, vaccine
0 Comment
Digital/ News/ News/ News/ R&D
EMA pilot will see if clinical trial data should be digested ‘raw’
Phil Taylor
clinical research, clinical trials, data, ema, regulatory
0 Comment
Market Access/ Oncology/ Views & Analysis/ Views & Analysis/ Views and analysis
Are timely access and robust safety mutually exclusive?
Amanda Barrell
EFPIA, ema, fda, Kristina Jenei, Oncology
0 Comment
Biogen pulls EU application for Alzheimer’s drug Aduhelm
Phil Taylor
Aduhelm, Alzheimer's disease, Biogen, CHMP, ema, EU, market access, neurology
0 Comment
EU says not enough evidence to warrant fourth COVID jabs
Phil Taylor
BioNTech, Comirnaty, coronavirus, COVID-19, COVID-19 vaccine, ema, fda, Moderna, Pfizer, Spikevax
0 Comment