Jaypirca (pirtobrutinib) — once-daily pill for adults with previously untreated CLL or SLL and no known 17p deletion
US label section 1.3 added 10/2026; BRUIN CLL-313 NCT05023980
This is for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not been treated before and have no known 17p deletion.
Olumiant (baricitinib) — once-daily pill for teens and adults with severe alopecia areata
US label expanded 09/2026 to ages 12+; EU SmPC already covers adolescents; BRAVE-AA-PEDS NCT05723198
This is for families and adults living with severe alopecia areata who are 12 years or older.
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…
Onswik (insulin efsitora alfa-gobe) — once-weekly basal insulin for adults with type 2 diabetes
Onswik (insulin efsitora alfa) is a once-weekly long-acting insulin for adults with type 2 diabetes.
This is for adults with type 2 diabetes — and caregivers helping them — who may be candidates for a once-weekly basal insulin instead of a daily basal shot.
Nezglyal (leriglitazone) — oral suspension for early cerebral adrenoleukodystrophy (Gd-negative)
The European Commission authorised Nezglyal (leriglitazone) on 21 September 2026, under exceptional circumstances.
This is for boys aged 2 to 12 with early cerebral adrenoleukodystrophy (cALD) — Gd-negative brain lesions on MRI and a Neurological Functional Score of 0 or 1…
Emcitate (tiratricol) — dispersible tablets for peripheral thyrotoxicosis in MCT8 deficiency
FDA approved Emcitate (tiratricol) tablets for oral suspension on 28 September 2026 — Novel Drug Approvals 2026 #45 — for treatment of peripheral…
This is for people living with MCT8 deficiency (Allan-Herndon-Dudley syndrome) — and the caregivers who help them — who need a realistic route to tiratricol.
Lytenava (bevacizumab-vikg) — ophthalmic VEGF inhibitor injection for wet age-related macular degeneration
FDA approval on 24 July 2026 for Lytenava (bevacizumab-vikg) injection — an ophthalmic VEGF inhibitor for intravitreal use — for neovascular (wet) age-related…
This is for adults with wet age-related macular degeneration who may be candidates for labelled US Lytenava monthly eye injections — the first FDA-approved…
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…
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.…
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.
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…