Regulatory Affairs Professionals Society

Euro Roundup: EMA finalizes reflection paper on biosimilar comparative efficacy studies

The European Medicines Agency has finalized its reflection paper on a tailored clinical approach to biosimilar development, ...
The Pharma Letter

Keytruda regimen wins EU nod in PD-L1-positive platinum-resistant ovarian cancer

Merck & Co’s Keytruda (pembrolizumab)—in combination with paclitaxel, with or without bevacizumab—has been approved in the ...

EMA validates indication extension application for Tryngolza® (olezarsen) for the treatment of severe hypertriglyceridemia (sHTG)

Sobi® (STO: SOBI) today announced that the European Medicines Agency (EMA) has validated an indication extension application for Tryngolza® (olezarsen) for the treatment of adult patients with severe ...
Medscape

EMA Backs Orodispersible Furosemide for Edema in Children

The European regulator recommends granting pediatric use marketing authorization for Bopediat to treat children with oedema ...
Pharmabiz

EMA recommends marketing authorisation in EU for Imdylltra to treat adults with extensive-stage small cell lung cancer

EMA recommends marketing authorisation in EU for Imdylltra to treat adults with extensive-stage small cell lung cancer: Amsterdam, The Netherlands Monday, March 30, 2026, 17:00 Hr ...
Medscape

EU Backs New Oral Option in Psoriatic Arthritis

The European Medicines Agency has endorsed expanded use of Sotyktu for psoriatic arthritis, recommending approval after clinical trials showed improvement in joint symptoms.
Pharmabiz

Bristol Myers Squibb transforms the classical Hodgkin lymphoma treatment paradigm with expanded US & EMA approvals for Opdivo

Bristol Myers Squibb transforms the classical Hodgkin lymphoma treatment paradigm with expanded US & EMA approvals for Opdivo: Princeton, New Jersey Monday, March 23, 2026, 17:00 ...