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The Latest Breaking News from The European Medicines Agency

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

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

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…

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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

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

Why Is Protalix BioTherapeutics Stock Falling On Friday?

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion for Protalix BioTherapeutics, Inc.’s (NYSE:PLX) and Chiesi Group’s partnered Elfabrio’s revised dosing schedule for Fabry disease.

Benzinga

Sarepta Gets Thumbs Down From Regulators Regarding Elevidys Gene Therapy

On Friday, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the conditional marketing authorisation (CMA) for Elevidys (delandistrogene moxeparvovec) for ambulatory individuals aged three to seven years with Duchenne muscular dystrophy (DMD).

Benzinga

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Eli Lilly's Early Alzheimer's Drug Recommended For Approval By European Drug Regulator's Panel

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Friday recommending Eli Lilly and Co.’s (NYSE:LLY) donanemab for early symptomatic Alzheimer’s disease in adults with confirmed amyloid pathology who are apolipoprotein E ε4 (ApoE4) heterozygotes or non-carriers.

Benzinga

EU regulator approves injectable HIV drug that experts say could help stop transmission

The European Medicines Agency has recommended authorizing a twice-yearly injectable drug to prevent HIV

The Independent UK

EU agency flags risks to nuclear medicines from dependency on Russia and US

Raw material dependency and transport bottlenecks, not just production capacity, are the key challenges facing the EU's radiopharmaceutical sector, according to the European Medicines Agency (EMA).

Euronews

Beware of unproven cancer treatments advertised online, EU medicine regulators say

The warning comes amid reports that unregulated therapies are being offered directly to patients, potentially illegally.

Euronews

3 High-Conviction Stocks with Strong Buy Ratings from Analysts

It’s easy to get caught up in market noise, but investing in companies backed by strong fundamentals and long-term growth potential can help investors stay the course even during market volatility. Thus, one could consider adding these three high-conviction pharmaceutical stocks, AbbVie (ABBV), Merck & Co. (MRK), and Bristol-Myers Squibb…

StockNews.com

3 Healthcare Innovators With Game-Changing Treatments

The pharmaceutical industry’s long-term growth is fueled by a surge in demand for personalized medicine, rising R&D initiatives, and the adoption of cutting-edge technologies. Hence, it could be ideal to buy fundamentally solid pharma stocks, Eli Lilly (LLY), Bristol-Myers (BMY), and Merck & Co. (MRK), which look poised for blockbuster…

StockNews.com

Top Biotech 3 Stocks With Accelerating Profits

The biotechnology industry is booming thanks to growing demand for innovative healthcare solutions, favorable government initiatives, and several scientific breakthroughs. Thus, quality biotech stocks Genmab (GMAB), Halozyme Therapeutics (HALO), and Vertex Pharmaceuticals (VRTX) could be ideal buys for substantial profits. Read more….

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WEKU

Treatment for acute sleeping sickness has been brutal — until now

An oral drug is proving an effective treatment for the acute strain of this potentially fatal disease — an alternative to injections of drugs that posed serious risks to the patient.

Reuters

EU backs use of Novo Nordisk's weight loss drug in adolescents

The European Medicines Agency said on Friday its committee has recommended expanding the use of Danish drugmaker Novo Nordisk's weight loss drug in adolescents aged 12 years and older.

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