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Understand new treatments and trials: who they may help, what the evidence shows, and how access differs by country.

Health Canada/FDA ApprovedUnited States, Canada, Switzerland, European Union

Once-Weekly Oral Medicine for Kids’ BRAF Brain Tumors

Ojemda (tovorafenib) — once-weekly oral RAF inhibitor for BRAF-altered pediatric low-grade glioma

This is for children and young people — and caregivers — facing relapsed or refractory pediatric low-grade glioma with a BRAF fusion, rearrangement, or V600 mutation after prior systemic therapy.

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 (ERBB2) tyrosine kinase domain activating…

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 without cirrhosis or with compensated cirrhosis.

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.

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Special series

Breaking Out: The Weight Class — Shots, Pills, and Organ Labels in 2026

Shots, pills, and organ labels in the 2026 weight class — Wegovy injection, Zepbound, the oral maze, and the process line that authorized is not funded. International by default. Zoom by country. Authorized is not funded.

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The next wave of treatment

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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.

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. Health Canada NOC was not retrieved.

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 first-start drug.

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 separate. Health Canada under review.

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 warning. Health Canada NOC was not retrieved — Canada is not dual-approved.

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 cholangitis (PBC) in adults.

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.

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.

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 is waiting on a Commission decision.