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New Developments

International coverage of treatments and trials, with the ability to zoom in on countries we cover. From approved options to compassionate access.

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Health Canada/FDA ApprovedUnited StatesCanadaJapanEuropean Union

New Pill for Hormone-Positive Advanced Breast Cancer

Etcamah (camizestrant) — oral ER antagonist with CDK4/6 for ESR1m HR+/HER2− advanced breast cancer

FDA accelerated approval on 4 September 2026 for Etcamah (camizestrant) tablets — an oral estrogen receptor antagonist — in combination with…

This is for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer who are…

Once-Weekly Insulin Shot for Adults with Type 2 Diabetes

Awiqli (insulin icodec / insulin icodec-abae) — once-weekly basal insulin

The first labelled once-weekly basal insulin. The United States (FDA, 26 Mar 2026) labels it only for adults with type 2 diabetes as an adjunct to diet…

The first labelled once-weekly basal insulin. The United States (FDA, 26 Mar 2026) labels it only for…

New Pill for Chronic Hives Not Controlled by Antihistamines

Rhapsido (remibrutinib) for adult chronic spontaneous urticaria still active on H1 antihistamines

The FDA, Health Canada, the European Commission, and the UK MHRA have labelled an oral BTK inhibitor — 25 mg twice daily — for adults with chronic spontaneous…

The FDA, Health Canada, the European Commission, and the UK MHRA have labelled an oral BTK inhibitor — 25 mg…

Health Canada/FDA ApprovedUnited StatesCanadaEuropean Union

First FDA-Approved Treatment for Chronic Hepatitis D

Hepcludex (bulevirtide) for chronic hepatitis D (HDV)

The first labelled drug for chronic hepatitis D. The United States (FDA accelerated, 22 May 2026) labels 8.5 mg subcutaneously once daily for adults…

The first labelled drug for chronic hepatitis D. The United States (FDA accelerated, 22 May 2026) labels…

Twice-Yearly Shot for a Severe Type of Asthma

Exdensur (depemokimab) for severe eosinophilic asthma — and, outside the United States, for nasal polyps

The FDA, Health Canada, the UK MHRA, Japan’s MHLW, the EU Commission, and (on the Australian PI) the TGA have labelled a twice-yearly anti-IL-5 injection. The…

The FDA, Health Canada, the UK MHRA, Japan’s MHLW, the EU Commission, and (on the Australian PI) the TGA have…