Resubmission of the supplemental biologics license application provided more data on improvement in hives and itching in ...

Raw material dependency and transport bottlenecks, not just production capacity, are the key challenges facing the EU's radiopharmaceutical sector, according to the European Medicines Agency (EMA).

Eisai and Biogen can finally put their European regulatory uncertainty surrounding Alzheimer's disease medicine Leqembi ...

The EMA has approved Cullinan Therapeutics’ clinical trial application for CLN-978, a drug intended to treat rheumatoid ...

The European Commission on Tuesday authorized the use of Eisai and Biogen's drug to treat some patients with mild cognitive impairment in the early stages of Alzheimer's disease, ending a more than ...

Cullinan Therapeutics (CGEM) announced that the European Medicines Agency, EMA, approved the Company’s Clinical Trial Application, CTA, for ...

Scholar Rock Holding Corporation's apitegromab shows promise for SMA treatment, aims for 2025 launch. Click for my updated ...

A new international study reveals a possible connection between GLP1 receptor agonists—used in drugs like Ozempic—and ...

Crofelemer, a novel plant-based anti-secretory prescription drug, has been granted Orphan Drug Designation by the FDA and the European Medicines Agency (EMA) for both short bowel syndrome (SBS) and mi ...

The European Commission said Wednesday that it had given formal approval for Leqembi, a long awaited new treatment for early ...

A Pembrokeshire dairy farming family have made significant strides in reducing their antibiotics use on-farm by using ...