Authorization Received from UK and EU Authorities to Activate ex-US Clinical Trial Sites Supporting the Ongoing Patient Enrollment of FT819, an ...

Expects to Submit Conditional Marketing Approval Application in Europe for Iopofosine I 131 in Refractory (post-BTKi) ...

Our productive engagement with the European Medicines Agency (EMA) highlighted by confirmation of eligibility to submit for a conditional ...

Research on adults who take S.S.R.I.s shows they tamp down sexual desire. Why aren’t we studying what that could mean for ...

Pharmacy and Poisons Board is at the forefront of a plan to eliminate drug approval bottlenecks and ensure timely access to ...

The inequitable distribution of vaccines during the COVID-19 pandemic was the final proof of the need for more home-grown ...

The African Medicines Agency (AMA) will be officially launched this week in Mombasa, Kenya, at the 7th Conference of African Medicines Regulatory Authorities (SCOMRA), which gets underway Tuesday, ...

Following the NDA submission for icotrokinra treatment of adults and adolescents with moderate to severe plaque psoriasis to the U.S. FDA in July, the European Medicines Agency (EMA) application was ...

The new EU regulation introduces Joint Clinical Assessments that will run in parallel with EMA approvals, delivering comparative effectiveness data within one month of market authorisation.

Celebrating Britain's swift approval of BioNtech and Pfizer's coronavirus vaccine as a benefit of Brexit is misplaced since ...

The European medicines regulator said on Tuesday some COVID-19-related documents and data that were accessed in a cyber ...