Europe shows no signs of antibiotic shortages this winter, EU medicines agency says

After years of winter medicine shortages, the European Medicines Agency told Euronews that there are currently no signs of ...
Fierce Pharma

With eye on supply chain resilience and domestic production, EU nudges closer to drug shortage prevention framework

As the U.S. focuses on beefing up its biopharma manufacturing infrastructure this year, a similar effort toward improved drug ...
PharmiWeb

European Medicines Agency (EMA) grants Orphan Drug Designation to Kedrion's plasma-derived treatment for Congenital Aceruloplasminemia, a rare genetic disorder of iron metabolism

This designation marks a significant milestone for patients and reaffirms Kedrion's commitment to addressing unmet medical needs in rare and ultra-rare diseasesCASTELVECCHIO PASCOLI, Italy, Nov. 27, ...
Consilium

New rules for critical medicines in the EU

The critical medicines act addresses shortages of key medicines to better meet patient needs and improve the EU’s resilience ...
Business Insider

Cellectar Biosciences Announces European Medicines Agency (EMA) Confirms Eligibility to File for Conditional Marketing Authorization (CMA) for Iopofosine I 131 as a Treatment ...

Following Scientific Advice and Guidance from Scientific Advice Working Party (SAWP) of EMA, Submission of CMA Application for Iopofosine I 131 as a Treatment for Refractory (post-BTKi) WM Expected in ...

Pre-filled Syringe Presentation of BYOOVIZ®, Samsung Bioepis' Biosimilar to Lucentis (Ranibizumab), Gains European Approval

European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for ...
dvm360

European agency recommends marketing authorization for avian flu vaccines

The European Commission will ultimately decide on whether marketing authorizations under exceptional circumstances for Vaxxitek HVT+IBD+H5 and Vaxxinact H5 will be granted. These decisions are ...
Morningstar

Zevra Therapeutics Submits Marketing Authorization Application to European Medicines Agency to Review Arimoclomol for the Treatment of Niemann-Pick Disease Type C

CELEBRATION, Fla., July 28, 2025 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with ...