Treatment type
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.
Camzyos (mavacamten) — oral treatment for symptomatic obstructive HCM from about 66 lb
US label expanded 9/2026 to patients ≥30 kg including eligible adolescents; SCOUT-HCM NCT06253221; REMS required
This is for families living with symptomatic obstructive hypertrophic cardiomyopathy when the person weighs at least 30 kg (about 66 lb).
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…
Juvmo (tavapadon) — selective D1/D5 dopamine agonist for Parkinson’s disease in adults
Juvmo (tavapadon) is a once-daily pill for adults with Parkinson’s disease.
This is for adults with Parkinson’s disease — and caregivers — who need a labelled once-daily oral option that can be used with or without levodopa.
Atebrioz (zilurgisertib) — oral ALK2 inhibitor to reduce new heterotopic ossification in FOP (ages 12+)
Atebrioz (zilurgisertib) is a once-daily pill for fibrodysplasia ossificans progressiva in people 12 and older.
This is for teens 12 and older and adults with fibrodysplasia ossificans progressiva (FOP) — and caregivers — who need a labelled way to slow new extra bone…
Lyrfigtu (lirafugratinib) — oral FGFR2 inhibitor for previously treated FGFR2-altered cholangiocarcinoma
The United States approved Lyrfigtu (lirafugratinib) on 23 September 2026. It is for adults with bile duct cancer that cannot be removed or has spread, with an…
This is for adults with previously treated unresectable, locally advanced, or metastatic bile duct cancer (cholangiocarcinoma) that harbors an FGFR2 gene…
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.
Aqneursa (levacetylleucine) — oral suspension for ataxia in ataxia-telangiectasia
FDA labelled expansion on 18 September 2026 for Aqneursa (levacetylleucine) for oral suspension — for the treatment of ataxia in adult and pediatric patients…
This is for people living with ataxia-telangiectasia — and the caregivers who help them — who weigh at least 15 kg and may be candidates for labelled US…
Kerendia (finerenone) — once-daily oral pill to lower urine protein in adults with kidney disease and type 1 diabetes
FDA supplemental approval announced 17 September 2026 for a new use of Kerendia (finerenone) tablets — a once-daily oral non-steroidal mineralocorticoid…
This is for adults with type 1 diabetes who already have chronic kidney disease with protein in the urine and may be candidates for labelled US Kerendia as a…
Joenja (leniolisib) — first labelled oral treatment for children 4–11 with APDS who weigh at least 27 kg
FDA supplemental approval on 11 September 2026 for Joenja (leniolisib) tablets — expanding the approved APDS pathway to adult and pediatric patients 4 years of…
This is for caregivers of children 4–11 years with genetically confirmed APDS who weigh at least 27 kg (about 60 lb) and who may be candidates for labelled US…
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…
Lifyorli (relacorilant) — oral GR antagonist with nab-paclitaxel for platinum-resistant ovarian cancer
FDA traditional (full) approval on 25 March 2026 for Lifyorli (relacorilant) capsules — an oral glucocorticoid receptor (GR) antagonist — in combination with…
This is for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after one to three prior systemic regimens…
Beqalzi (sonrotoclax) — oral BCL-2 inhibitor for R/R mantle cell lymphoma after ≥2 lines including a BTK inhibitor
FDA accelerated approval on 13 May 2026 for Beqalzi (sonrotoclax) tablets — an oral BCL-2 inhibitor — for adults with relapsed or refractory mantle cell…
This is for adults with relapsed or refractory mantle cell lymphoma who have already had at least two systemic treatments, including a BTK inhibitor, and who…
Zenbexus (iberdomide) — first labelled CELMoD for adults with multiple myeloma after ≥1 prior line
FDA accelerated approval on 13 August 2026 for Zenbexus (iberdomide) capsules — an oral cereblon-modulating protein degrader (CELMoD) — in combination with…
This is for adults with multiple myeloma who have already had at least one prior treatment that included a proteasome inhibitor and an immunomodulatory drug…
Jideytro (zidesamtinib) — oral ROS1 kinase inhibitor after a prior ROS1 TKI
On 22 July 2026 the FDA labelled Jideytro (zidesamtinib) tablets for adults with locally advanced or metastatic ROS1-positive NSCLC who received a prior ROS1…
Jideytro is a US-labelled oral pill for adults whose ROS1-positive lung cancer has already been treated with another ROS1 kinase inhibitor.
Xocova / Zokovea (ensitrelvir) — oral COVID-19 post-exposure prophylaxis
The first FDA-labelled oral option for COVID-19 post-exposure prophylaxis (PEP).
Xocova (ensitrelvir) is the first pill approved in the United States to help prevent COVID-19 after contact with someone who has it.
Utebzi (tebipenem pivoxil) — first oral carbapenem for adults with complicated UTI
The first FDA-approved oral carbapenem for adults.
Utebzi (tebipenem pivoxil) is the first carbapenem antibiotic pill approved in the United States.
Veppanu (vepdegestrant) — first FDA-approved PROTAC for ESR1-mutated ER+/HER2− advanced breast cancer
The FDA labelled a once-daily 200 mg oral PROTAC estrogen-receptor degrader tablet — take with food, swallow whole — for adults with ER-positive…
Veppanu (vepdegestrant) is a daily pill.
Baxfendy (baxdrostat) — first aldosterone-synthase inhibitor for adults whose blood pressure is not adequately controlled
The FDA labelled a once-daily 1 mg or 2 mg oral aldosterone synthase inhibitor tablet — take with or without food, swallow whole — in combination with other…
Baxfendy (baxdrostat) is a once-daily pill for adults whose high blood pressure is not controlled on other medicines.
Icotyde (icotrokinra) for moderate-to-severe plaque psoriasis — 12 and older, at least 40 kg
The FDA labelled a once-daily 200 mg oral IL-23 receptor peptide for moderate-to-severe plaque psoriasis in people 12 and older who weigh at least 40 kg and…
Icotyde (icotrokinra) is a once-daily pill for moderate to severe plaque psoriasis.
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).
Lipfendra (enlicitide) — first oral PCSK9 inhibitor for high LDL-C in adults
The FDA labelled a once-daily 20 mg oral PCSK9 inhibitor tablet — take in the morning on an empty stomach — as an adjunct to diet and exercise to lower LDL-C…
Lipfendra (enlicitide) is a daily pill taken on an empty stomach. The United States approved it, with diet and exercise, to lower “bad” cholesterol 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.
Orzeyful (oveporexton) is approved in the United States for adults with narcolepsy type 1. It cannot be sold there until the Drug Enforcement Administration…
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.
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…