New and rare medicines 2026: a review of the latest arrivals on the European pharmaceutical market

On the aquis-apteka.com blog we cover new and rare medicines that have recently appeared on the European market or are in the final stages of development. Here you will find up-to-date reviews of medicines approved by the European Medicines Agency (EMA) and its CHMP committee, as well as forecasts from leading industry organisations, including the German Association of Pharmaceutical Manufacturers (vfa).

We cover the key areas: oncology medicines, medicines for rare genetic and autoimmune diseases, new agents for the treatment of lung diseases, metabolic disorders, and neurological and infectious conditions. Particular attention is given to medicines for patients whose standard treatment regimens have been exhausted.

If you are interested in the availability of a specific medicine from Germany or the possibility of ordering it with delivery to Europe and the CIS, please contact the consultants at aquis-apteka.com. We help to source rare medicines that are difficult to obtain through ordinary channels.

The year 2026 promises to be one of the most eventful in the history of European pharmaceuticals. According to the European Medicines Agency, more than 45 new medicines have already been approved or are awaiting a final decision, and almost a third of them are intended for the treatment of rare diseases. We share a selection of the most significant new arrivals.

Breakthroughs in oncology

Imdylltra (tarlatamab) — against small cell lung cancer

In March 2026, the CHMP recommended for approval Imdylltra — the first bispecific medicine for the treatment of relapsed extensive-stage small cell lung cancer. Until now, patients with this aggressive form of cancer have had extremely limited treatment options after the failure of first-line therapy. Details are available on the EMA website.

Etcamah (camizestrant) — targeted therapy for breast cancer

In May 2026, a positive CHMP opinion was granted to Etcamah for the treatment of locally advanced or metastatic breast cancer with a specific ESR1 gene mutation. The medicine offers a targeted approach for the group of patients who respond poorly to standard hormone therapy.

Adstiladrin (nadofaragene firadenovec) — gene therapy for bladder cancer

This medicine became the first gene therapy recommended for conditional approval in the EU for the treatment of non-muscle-invasive bladder cancer that does not respond to Bacillus Calmette-Guérin (BCG) vaccine therapy.

Lung diseases

Jascayd (nerandomilast) — against idiopathic pulmonary fibrosis

One of the most anticipated new arrivals of 2026. Jascayd received a positive CHMP opinion in May 2026 for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) — two severe diseases in which lung tissue becomes irreversibly scarred. The arrival of a new medicine is especially important, as treatment options for these diseases have so far been extremely scarce.

Brinsupri (brensocatib) — for patients with bronchiectasis

Approved in October 2025, the medicine Brinsupri from Insmed is the first inhibitor of the DPP1 enzyme for the treatment of non-cystic fibrosis bronchiectasis — a chronic lung disease that until now has had no specific therapy.

Rare diseases

Vijoice (alpelisib) — PROS syndrome

Conditional approval was granted to the medicine Vijoice for the treatment of severe forms of PIK3CA-related overgrowth spectrum (PROS). This is a group of extremely rare genetic diseases for which no approved medicines previously existed.

Joenja (leniolisib) — APDS syndrome

Approved in March 2026 for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) — a rare primary immunodeficiency in adolescents and adults.

Kygevvi (doxecitine/doxribtimine)

The medicine from UCB Pharma, approved in January 2026, is intended for the treatment of a rare mitochondrial disease in children and adults.

Wayrilz (rilzabrutinib) — immune thrombocytopenia

This BTK inhibitor from Sanofi, approved in October 2025, opens up new opportunities in the treatment of immune thrombocytopenia — a disease associated with a pathologically low platelet count.

Neurology and immunology

Imaavy (nipocalimab) — generalised myasthenia gravis

This selective immunosuppressant from Janssen-Cilag, approved in September 2025, expands the therapeutic arsenal for this severe autoimmune neurological disease.

Metabolic diseases and endocrinology

Kayshild (semaglutide) — fatty liver disease

In January 2026, Novo Nordisk obtained approval for Kayshild for the treatment of non-cirrhotic metabolic dysfunction-associated steatotic liver disease (MASLD/MASH) — a disease that affects millions of people in Europe and that until recently had virtually no drug therapy.

Wegovy (semaglutide) — oral form

In May 2026, the CHMP recommended an extension of use for Wegovy: the weight-loss medicine will now also be available as daily tablets as an alternative to weekly subcutaneous injections.

Lynkuet (elinzanetant) — menopausal hot flushes

This non-hormonal medicine from Bayer, approved in September 2025, offers menopausal women an alternative to hormone replacement therapy for the treatment of vasomotor symptoms.

Infectious diseases

Enflonsia (clesrovimab) — protecting infants from RSV

This monoclonal antibody from Merck Sharp & Dohme, approved in September 2025, is intended for the prevention of severe lower respiratory tract infections caused by respiratory syncytial virus (RSV) in infants.

In the final stages of development

Daraxonrasib (RMC-6236) — a revolution in the treatment of pancreatic cancer

In April 2026, the results of the phase III study RASolute 302, in which the medicine daraxonrasib showed unprecedented results: the median survival of patients with metastatic pancreatic cancer was 13.2 months versus 6.7 months on standard chemotherapy — a reduction in the risk of death of approximately 60%. The medicine is taken orally once a day and is currently undergoing registration procedures (Revolution Medicines, Digestive Cancers Europe).

A combined mRNA vaccine against influenza and COVID-19

According to vfa forecasts, in 2026 Europe may see the arrival of the world’s first combined vaccine against both seasonal influenza and COVID-19, based on mRNA technology.

Medicines against various types of cancer

According to forecasts, about a third of all new arrivals in 2026 will be oncology medicines — including up to three new medicines for small cell and non-small cell lung cancer, up to three for bladder cancer, and two for breast cancer. Among them are new checkpoint inhibitors, kinase inhibitors, and bispecific antibodies.

What we cannot yet expect: new antibiotics

Unfortunately, the appearance of new antibiotics on the European market in 2026 is unlikely. According to vfa, at present no new antibiotic is in the EMA approval procedure. This causes serious concern among specialists, as the problem of bacterial resistance to existing medicines continues to grow.

Conclusion

The year 2026 brings real hope to patients with hard-to-treat diseases — from rare genetic syndromes to aggressive forms of cancer. It is especially encouraging that almost a third of all new approvals are devoted to rare diseases for which no treatment options previously existed. However, the question of new antibiotics remains open and requires the attention of both developers and regulators.

We will continue to monitor developments and keep you informed about new medicines appearing on the European market. If you are interested in the availability of a specific medicine or the possibility of ordering it, please contact our consultants.

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The information in this article is for reference only and does not replace a doctor’s consultation. All medicines must be prescribed by a qualified specialist.