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The Latest Breaking News from EMA

Capricor Therapeutics Q1 Earnings Call Highlights

Capricor Therapeutics (NASDAQ:CAPR) said its Duchenne muscular dystrophy therapy candidate deramiocel remains under active FDA review, while the company is preparing to commercialize the product itself amid a legal dispute with distribution partner NS Pharma and parent company Nippon Shinyaku. On t

MarketBeat

Anavex Life Sciences Stock Is Deeply Oversold. Should You Buy the Dip?

Anavex shares crash as the EMA indicates it won’t issue a positive opinion on its candidate Alzheimer’s drug. Here’s why long-term investors may still consider loading up on AVXL stock today.

Barchart

Blame U.S. Regulations for China's Dominance in Rare-Earth Minerals

America once dominated the rare-earth market, but permitting requirements are holding the industry back.

Reason

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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

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

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

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Misleading claims about EU's approval of COVID vaccines persist online

The approval of COVID-19 vaccines may have been fast-tracked, but these medicines were still subject to rigorous checks carried out by regulatory authorities.

Euronews

European Medicines Agency refutes Trump's link between paracetamol and autism

The European Medicines Agency (EMA) joined a chorus of medical opinion stating on Tuesday that paracetamol is safe to use during pregnancy and that there is no evidence linking it to autism, contrary to claims made this week by the US president.

Euronews

EU medicine shortages at record levels, auditors report

Medicine shortages have been a recurring issue throughout the bloc for years, but the EU still lacks an effective system to deal with them, according to a new report by the European Court of Auditors (ECA).

Euronews

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

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 regulators give backing to first-of-its-kind inhaler that is more climate-friendly

Inhalers may be small, but they can make a big impact on the environment.

Euronews

EU regulator backs new Alzheimer’s treatment, reversing initial decision to reject it

An expert committee recommended that the drug be offered to a narrow group of patients with early-stage Alzheimer’s disease.

Euronews

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Euronews

EU regulators greenlight twice-yearly HIV injection, hailed as medical breakthrough

The drug is expected to be formally approved by the European Commission this year.

Autosport

DTM Norisring: Preining triumphs in chaotic race from Aitken

Manthey Porsche driver Thomas Preining clinched victory in the second DTM race of the Norisring round.

Motorsport

DTM Norisring: Thomas Preining wins chaotic race

Manthey Porsche driver Thomas Preining clinched victory in the second race of the Norisring round in the 2025 DTM season.

Euronews

Police seize €57 million in illegal Ozempic, peptides, and other black market drugs in global bust

Interpol cited a concerning rise in demand for unauthorised weight loss drugs and peptide supplements in Europe and other wealthy regions.

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Motorsport

Nurburgring 24 Hours: BMW wins after penalty for Porsche

Rowe BMW took Nurburgring 24 Hours victory after a penalty for the leading Manthey EMA Porsche following a clash, which meant that victory went to Raffaele Marciello, Kelvin van der Linde, Jesse Krohn and Augusto Farfus.

Autosport

Nurburgring 24 Hours: BMW wins after post-race penalty for Porsche

Radio France Internationale

Harare goes green: capital city leads Zimbabwe’s climate fight with bold urban solutions

Harare, the capital of Zimbabwe, is fast becoming a key player in the battle against climate change, developing innovative approaches to tackle waste management, restore degraded ecosystems, and promote sustainable urban planning. Like many other cities across the globe, Harare faces significant environmental challenges - yet it is also a…

Euronews

Men’s hair loss treatment linked to rare risk of suicidal thoughts, EU medicines regulator says

The medicine will remain on the shelves but will come with additional warnings about the side effects, which appear to be rare.

Euronews

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

EU regulators block new Alzheimer’s drug citing potentially fatal side effects

The company behind the drug donanemab said it will ask regulators to reconsider the decision.

Medical Daily

Addressing Challenges in Rare Disease Clinical Trials: Strategies for Success with iNGENū CRO

iNGENū CRO leverages global expertise, advanced technology, and strategic funding to overcome rare disease trial challenges.

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