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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…

Health Canada/FDA ApprovedUnited StatesCanada

New Weekly Enzyme Treatment for Arginase-1 Deficiency

Loargys (pegzilarginase-nbln) for arginase-1 deficiency (ARG1-D)

The FDA (accelerated, 23 Feb 2026) and Health Canada (full NOC, 29 May 2026) have labelled a weekly enzyme replacement for hyperargininemia in people 2 years…

The FDA (accelerated, 23 Feb 2026) and Health Canada (full NOC, 29 May 2026) have labelled a weekly enzyme…

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…

Health Canada/FDA ApprovedUnited StatesCanada

Once-Daily Switch Pill for Adults with Suppressed HIV

Idvynso (doravirine/islatravir) for HIV-1 — switch-only dual tablet

Health Canada and the FDA labelled a once-daily doravirine/islatravir tablet as a switch option for adults with HIV-1 who are already suppressed — not a…

Health Canada and the FDA labelled a once-daily doravirine/islatravir tablet as a switch option for adults…

Health Canada/FDA ApprovedUnited StatesCanada

New Pill for a Gene-Related Advanced Lung Cancer

Hyrnuo (sevabertinib) for HER2 TKD-mutant NSCLC

The FDA and Health Canada have labelled an oral HER2 tyrosine-kinase inhibitor for adults with locally advanced or metastatic NSCLC whose tumours have HER2…

The FDA and Health Canada have labelled an oral HER2 tyrosine-kinase inhibitor for adults with locally…

Health Canada/FDA ApprovedUnited StatesCanada

Injection Treatment When the Body Makes Too Many Eosinophils

Fasenra (benralizumab) for hypereosinophilic syndrome

Health Canada and the FDA have labelled Fasenra for hypereosinophilic syndrome. Japan and Switzerland have too. The UK SmPC already carries the wording. The EU…

Health Canada and the FDA have labelled Fasenra for hypereosinophilic syndrome. Japan and Switzerland have…