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.

NEW YORK CITY, NY / ACCESS Newswire / April 3, 2025 / Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies ...

The European Commission has referred Eisai and Biogen’s application to an appeals committee. Elsewhere, Opthea warned of ...

Icelandic drug discovery and development company Arctic Therapeutics (ATx) today announced the publication of research in JAMA Neurology, which informs a possible therapeutic strategy to treat a rare ...

Eli Lilly's Alzheimer's treatment is approved for use in the U.S. but the European Medicines Agency recommended against the ...

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

Accord Healthcare Limited (Accord) is pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for ...

A key result of a workshop series of European regulatory authorities and HTA agencies: Drug studies should be designed in such a way that they address both regulatory questions and the essential ...

It is a biologic product used to treat children and adolescents from 2 to 18 years-old who suffer from severe primary insulin-like growth ...

M Co., Bioject Medical Technologies Inc., Valeritas Inc., Antares Pharma Inc., and Endo International PLC Lead the Competitive LandscapeDublin, April 01, 2025 (GLOBE NEWSWIRE) -- The "Needle Free ...

Novo Nordisk today presented the full results from the SOUL cardiovascular outcomes trial, demonstrating that Rybelsus® (oral ...