Amid a raft of federal changes cutting funding and capacities at the Food and Drug Administration, investors are soon ...

In response to a request from the European Medicines Agency (EMA) following the death of a 16-year-old patient in the U.S., ...

The European Medicines Agency asked for three clinical trials to be placed on hold until the exact cause of death of a US ...

This article examines post-market drug safety, highlighting surveillance mechanisms, regulatory responses, and case studies of approved drugs with hidden risks.

Akebia Therapeutics gets EMA panel support for Xoanacyl to treat high phosphate & iron deficiency in CKD. Read more here.

Shares of Sarepta Therapeutics (NASDAQ:SRPT) fell in the premarket on Thursday following news regarding a clinical hold ...

MSD’s monoclonal antibody, indicated for 15 types of cancer, smashed industry records with sales of $27.3 billion in 2024, ...

The European Medicines Agency (EMA) announced it is exploring improvements to the development and evaluation of biosimilar ...

CHMP recommends approval for XOANACYL, an oral therapy for use in the following therapeutic areas: Iron deficiency, chronic renal failure and ...

Roberta Cannella, Chief Technical Officer, commented: "This submission brings us closer to offering patients a new option for AKYNZEO ®. It not only demonstrates our commitment to enhancing patients' ...

The pandemic showed just what can be achieved with faster and more efficient regulatory approval — the same approach needs to be applied now to save patients’ lives and tackle the growing burden ...

Corcept's relacorilant hits phase 3 trial success in ovarian cancer, lifting shares 90%. Click here to find out why I rate ...