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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…

New Oral Medicine for Narcolepsy Type 1 in Adults

Orzeyful (oveporexton) for narcolepsy type 1

The FDA labelled oveporexton for adults with narcolepsy type 1 on 5 August 2026 — and said it will be lawful to market only after DEA scheduling. Japan’s PMDA…

The FDA labelled oveporexton for adults with narcolepsy type 1 on 5 August 2026 — and said it will be lawful…

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…

Weekly Shot When Too Many Red Blood Cells Need Frequent Draws

Mimrylo (rusfertide) for erythrocytosis in adults with polycythemia vera (PV)

The FDA labelled a once-weekly subcutaneous hepcidin mimetic for adults with polycythemia vera who still need frequent phlebotomies despite standard care.…

The FDA labelled a once-weekly subcutaneous hepcidin mimetic for adults with polycythemia vera who still need…

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…

New Daily Pill for Chronic Weight Management in Adults

Foundayo (orforglipron) for chronic weight management

FDA labelled oral orforglipron for chronic weight management in adults. UK MHRA also labelled weight management and type 2 diabetes — those lines stay…

FDA labelled oral orforglipron for chronic weight management in adults. UK MHRA also labelled weight…

New Daily Pill for Adult Muscle and Skin Inflammation

Lisraya (brepocitinib) — first oral TYK2/JAK1 tablet labelled for adult dermatomyositis

FDA labelled a once-daily 30 mg pill for dermatomyositis in adults (27 August 2026), with a boxed JAK-class…

New Pill for Itch from a Bile-Duct Disease

Lynavoy (linerixibat) for cholestatic itch in adults with primary biliary cholangitis — oral IBAT inhibitor

The FDA (17 Mar 2026) and UK MHRA (1 May 2026) labelled an oral 40 mg tablet twice daily for cholestatic pruritus associated with primary biliary…

The FDA (17 Mar 2026) and UK MHRA (1 May 2026) labelled an oral 40 mg tablet twice daily for cholestatic…

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…

New Pill for Advanced Pancreatic Cancer

Rasonque (daraxonrasib): the first RAS(ON) pill for metastatic pancreatic adenocarcinoma

The FDA approved this RAS(ON) pill on 26 August 2026 for metastatic pancreatic adenocarcinoma. It is not a Canadian pharmacy drug. SAP, a first-line trial…

The FDA approved this RAS(ON) pill on 26 August 2026 for metastatic pancreatic adenocarcinoma. It is not a…

New Pill for Scarred-Lung Disease in Adults

Jascayd (nerandomilast) for IPF and PPF

The FDA, Europe, and the UK have labelled nerandomilast for adults with idiopathic pulmonary fibrosis and for adults with progressive pulmonary fibrosis.…

The FDA, Europe, and the UK have labelled nerandomilast for adults with idiopathic pulmonary fibrosis and for…

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…

New Pill When the Heart Muscle Is Too Thick

Myqorzo (aficamten) for obstructive hypertrophic cardiomyopathy

The FDA, Europe, the UK, and China have labelled aficamten for symptomatic obstructive HCM in adults. England's NHS has a 30-day funding clock from NICE.…

The FDA, Europe, the UK, and China have labelled aficamten for symptomatic obstructive HCM in adults.…