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.
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…
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.
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.
Breakthrough Brief
New treatments and trials, weekly. Every email has an unsubscribe link.
By subscribing, you request Breakthrough Brief emails. Privacy
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.
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.
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.
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.
The FDA, Europe, and the UK have labelled nerandomilast for adults with idiopathic pulmonary fibrosis and for adults with progressive pulmonary fibrosis.
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.