The Latest Breaking News from The European Medicines Agency

FDA Flagged GLP-1 Vision Loss Signal in 2025, but U.S. Ozempic and Mounjaro Labels Still Lack NAION Warning

FDA listed NAION as a possible GLP-1 safety signal in March 2025, yet U.S. labels still lack a warning, while Europe, the UK, and Australia have acted.

Medical Daily · Sep 29

Biocon arm gets positive EMA panel recommendation for breast cancerbiosimilar Pebrilzo

Biocon Biologics has received a positive recommendation from the European Medicines Agency’s CHMP for its Pertuzumab biosimilar, Pebrilzo, for HER2-positive breast cancer. The European Commission will take the final decision on marketing authorisation across the EU.

The Economic Times · Sep 21

Newborns with HIV Can Now Get a Second Generation Antiviral from Birth Under a Newly Expanded Federal Label

The FDA extended Tivicay PD to newborns from birth weighing at least 2 kg, closing a long-standing gap in infant HIV treatment options.

Medical Daily · Aug 26

Where do Europeans wait longest for new medicines?

Access to new medicines still varies sharply across Europe, with waits ranging from months to more than three years, according to the European Federation of Pharmaceutical Industries and Associations.

Euronews · May 20

Why drug approval in Canada should not rely on foreign regulators

Without much fanfare, Health Canada announced in the Canada Gazette Part 1 on Dec. 22, 2025 that it was beginning a 70-day consultation period on using the decisions of foreign drug regulators such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to approve new…

The Conversation · Jan 29

Why Requirements Management Is Critical in Regulated Device Development

In the development of regulated medical devices, adherence to stringent regulatory requirements is not optional but a foundational necessity. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others around the world enforce strict guidelines to ensure the safety, efficacy, and reliability…

inkl · Dec 8, 2025

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 antibiotic shortages, amid EU efforts to reduce dependency on foreign suppliers.

Euronews · Nov 26, 2025

Moderna Q3 2025 Earnings Call Transcript

Moderna, Inc (NASDAQ:MRNA) reported third-quarter financial results on Thursday. The transcript from the company’s third-quarter earnings call has been provided below. MRNA is building positive momentum. Watch the momentum here This transcript is brought to you by Benzinga APIs. For real-time access to our entire catalog, please visithttps://www.benzinga.com/apis/for a consultation. Operator…

Benzinga · Nov 6, 2025

Major global travel and tourism group to quit London HQ and move to Europe because of Brexit

The World Travel and Tourism Council (WTTC) has become the latest major international institution to announce plans to close its doors on its headquarters in the UK

The Independent UK · Oct 29, 2025

Sanofi's Rezurock Approval Stumbles In EU For Chronic Graft-Vs-Host Disease

On Friday, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for Sanofi SA’s (NASDAQ:SNY) Rezurock (belumosudil).

Benzinga · Oct 17, 2025