Ojemda (tovorafenib) — once-weekly oral RAF inhibitor for BRAF-altered pediatric low-grade glioma
Ojemda (tovorafenib) is a weekly medicine for children’s low-grade glioma with certain BRAF gene changes, after earlier treatment.
This is for children and young people — and caregivers — facing relapsed or refractory pediatric low-grade glioma with a BRAF fusion, rearrangement, or V600…
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 a CDK4/6 inhibitor…
This is for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer who are already on an aromatase inhibitor plus a CDK4/6…
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…
Loargys (pegzilarginase) is a weekly enzyme treatment for arginase 1 deficiency in people 2 and older, used with a low-protein diet.
Awiqli (insulin icodec / insulin icodec-abae) — once-weekly basal insulin
The first labelled once-weekly basal insulin.
Awiqli (insulin icodec) is a once-weekly long-acting insulin. The United States approved it in March 2026 only for adults with type 2 diabetes.
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…
Rhapsido (remibrutinib) is a twice-daily pill for adults whose chronic hives continue despite antihistamines (United States, Canada, Europe, United Kingdom).
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…
Hepcludex (bulevirtide) is the first approved medicine for chronic hepatitis D. The United States gave accelerated approval to a daily 8.5 mg shot in May 2026.…
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.
Orzeyful (oveporexton) is approved in the United States for adults with narcolepsy type 1. It cannot be sold there until the Drug Enforcement Administration…
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.
Exdensur (depemokimab) is a shot given twice a year for severe eosinophilic asthma. In the United States, it is approved for this asthma in people 12 and older.
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.
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…
Idvynso (doravirine and islatravir) is a daily pill for adults whose HIV (human immunodeficiency virus) is already under control.
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.
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.
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…
Lynavoy (linerixibat) is a pill taken twice daily for itch caused by primary biliary cholangitis, a liver disease, in adults.
Hyrnuo (sevabertinib) for HER2 TKD-mutant NSCLC
Hyrnuo (sevabertinib) is a pill for adults with advanced lung cancer and a certain HER2 gene mutation.
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 licensed in Canada.
The FDA approved this RAS(ON) pill on 26 August 2026 for metastatic pancreatic adenocarcinoma. It is not a Canadian pharmacy drug.
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.
Jascayd (nerandomilast) is approved in the United States, Europe and the United Kingdom.
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.
Myqorzo (aficamten) for obstructive hypertrophic cardiomyopathy
The US, Europe, the UK and China have labelled aficamten for adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM).
Myqorzo (aficamten) is approved in the United States, Europe, the United Kingdom, China and Canada for adults with symptoms from obstructive hypertrophic…