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The Latest Breaking News from EMA

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

From Gujarat to Rio: How India's pollution solution could offer lessons for Delhi-NCR’s dirty air crisis

An Indian emissions trading scheme developed in Gujarat is now being explored internationally. This market-based approach encourages industries to reduce pollution through economic incentives. The successful pilot in Surat demonstrated significant emission reductions and cost savings for factories. This innovative model is now being considered for adoption in Rio de…

The Economic Times · Sep 14

UK Government urged to copy SNP support worth thousands for young people

SNP MP Lara Bird said the UK Government should back Scottish Government policies including free tuition and education support payments.

Evening Standard · Aug 9

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The Clinical Trial That Supported Tavneos for ANCA Vasculitis Was Just Retracted

NEJM retracted the Tavneos ADVOCATE trial on June 29, 2026, after FDA found altered patient data. Patients should not stop Tavneos without a doctor — here's what's known.

Medical Daily · Jul 7

Menarini Group Reports Data from the Phase 3 SENTRY Trial of Selinexor Plus Ruxolitinib in Myelofibrosis at The European Hematology Association (EHA) 2026 Congress

FLORENCE, Italy and NEW YORK, June 14, 2026 /PRNewswire/ -- The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, announced that new data related to the pivotal…

AAP · Jun 14

Why insulin, the core element of diabetes treatment remains inaccessible for millions of people

The discovery of insulin in 1921 revolutionised diabetes care. Type 1 diabetes went from being a death sentence to a manageable chronic condition.

The Conversation · Jun 4

Greece: Only one in five new medicines reaches patients – the 'legacy' of the bailouts

Greeks wait almost two years for access to new treatments, while pharmaceutical companies increasingly say they do not intend to launch new products in the country.

Euronews · May 28

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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

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 · May 12

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 · Mar 26

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 · Mar 21

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

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Benzinga · Oct 17, 2025

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.

Euronews · Oct 6, 2025

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 · Sep 23, 2025

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 · Sep 17, 2025

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).

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Benzinga · Jul 25, 2025

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 · Jul 25, 2025

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.

Euronews · Jul 25, 2025

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 · Jul 25, 2025

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 · Jul 25, 2025

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 · Jul 6, 2025

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 · Jul 6, 2025

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.

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