New EU regulations aim to speed up health technology assessments (HTAs), but the pharma industry raises logistical concerns.

Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) and sa-mRNA pioneer Arcturus Therapeutics (Nasdaq: ARCT) today ...

Pathways to success for this key component of Europe’s new HTA regulation, where thinking beyond the purely technical will be ...

The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...

The European Medicines Agency (EMA) announced on Monday that it will be discontinuing its presence on X, opting instead to utilize rival platform Bluesky.

CSL (CSLLY) and Arcturus Therapeutics (ARCT) announced that the European Commission has granted marketing authorization for Kostaive, a ...

Czechia proposes changes that will better define the role of patient organisations when informing patients about therapeutic procedures without violating advertising regulations.

Berlin: Bayer has submitted an application to the European Medicines Agency (EMA) to expand treatment intervals of up to 6 ...

CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee ...

The approval is based on positive results from the Phase 3 ATTRibute-CM study, in which acoramidis demonstrated the most rapid benefit seen in ...

Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative ...

Ocugen (OCGN) said it has received a positive opinion from EU regulators for Advanced Therapy Medicinal Product ...