Home » Topics » Regulatory » EMA

EMA
RSS

Pegasys receives E.U. approval for HCV in children 5 years of age and older

March 19, 2013

Activartis gives update on its anticancer immune therapy for glioma

March 14, 2013

Roche obtains E.U. approval for Perjeta

March 6, 2013

EMA grants orphan drug status to Prothena's candidate for amyloid light-chain amyloidosis

March 5, 2013

EMA recommends approval of Sanofi Pasteur pediatric vaccine

Feb. 27, 2013

EMA confirms decision on VIVUS' MAA for obesity treatment

Feb. 25, 2013

EMA grants orphan designation to BHR Pharma's investigational agent for traumatic brain injury

Feb. 14, 2013

Prolor Biotech's hGH-CTP receives orphan drug designation in Europe

Feb. 14, 2013

Pediatric indication of Ixiaro approved in Europe

Feb. 12, 2013

EMA committee begins safety review of Diane-35 and generics

Feb. 11, 2013

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for April 24, 2026.
A free gene therapy? Regeneron’s Otarmeni approved for hearing loss
BioWorld
Children and adults with a type of congenital hearing loss now have a free treatment option, with the U.S. FDA’s accelerated approval of Regeneron Pharmaceuticals...
Detecting the invisible: minimal residual disease at AACR 2026
BioWorld Science
Minimal residual disease (MRD) has become a central concept in modern oncology, reshaping how clinicians evaluate response, relapse risk and treatment precision....
AACR 2026: The age of agentic AI in oncology
BioWorld Science
New Approach Methodologies (NAMs) for drug development are transforming biomedical research by replacing or complementing animal models. More than 90% of...
In the clinic for April 21, 2026
BioWorld
Clinical updates for biopharma and med tech, including data readouts and publications: Abbott, Agenus, Astrazeneca, Briacell, Clearmind, Greenwich, Intodna,...