The European Medicines Agency (EMA) has approved Moleculin Biotech’s clinical trial application (CTA) for a pivotal, ...

Some U.S. biotech companies are considering moving early-stage trials of new medicines outside the United States as worry ...

In looking across the past four years of regulatory decisions, we noticed that some of the analyses involving the European Medicines Agency (EMA)'s cycle time used an inappropriate endpoint ...

The medicine will remain on the shelves but will come with additional warnings about the side effects, which appear to be ...

The European drugs regulator said on Thursday its safety panel has confirmed suicidal thoughts as a side effect of ...

The PDCO’s positive opinion is based on PolTREG’s original preTreg clinical trial protocol initiated in October 2024, which enrolled children aged 6–16 years in Stage 1 type 1 diabetes. In its ...

today announced that the European Medicines Agency (EMA) has approved its Clinical Trial Application (CTA) to conduct its pivotal Phase 2B/3, multi-center, randomized, double-blind, placebo ...

The European Medicines Agency has recommended marketing approval for Alyftrek for cystic fibrosis and Attrogy for a form of hereditary amyloidosis.

The U.S. Food and Drug Administration (FDA) on Wednesday approved Merck & Co. Inc.’s (NYSE:MRK) Welireg (belzutifan) for ...

Few areas of healthcare are as sensitive as cancer treatment. Each year, around 44,000 cancer tumours are diagnosed here.

Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin” or the "Company”), a late-stage pharmaceutical company with a broad ...