Quarterly Drug Approvals: April 2026
This report provides an overview of new drugs and indications approved in 2026
Specialty drug approvals
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Traditional drug approvals
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Cellular and gene therapy and biosimilar approvals
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AAVRh74var adeno-associated virus serotype Rh74var
ABSSSI acute bacterial skin and skin structure infections
AChR acetylcholine receptor
ADHD attention deficit hyperactivity disorder
ALK anaplastic lymphoma kinase
ALK+ anaplastic lymphoma kinase-positive
ALL acute lymphoblastic leukemia
AML acute myeloid leukemia
AQP4 anti-aquaporin-4
ARV antiretroviral
ASCT autologous stem cell transplant
ASPS alveolar soft part sarcoma
AVD doxorubicin, vinblastine and dacarbazine
BCG Bacillus Calmette-Guérin
BMI body mass index
BPH benign prostatic hyperplasia
BRAF v-raf murine sarcoma viral oncogene homolog B1
BRCA2 breast cancer gene 2
BTC biliary tract cancer
BTK Bruton tyrosine kinase
CAD coronary artery disease
CAR chimeric antigen receptor
CD19+ cluster of differentiate 19-positive
CD22+ cluster of differentiate 22-positive
CFTR cystic fibrosis transmembrane conductance regulator
CHF congestive heart failure
CIDP chronic inflammatory demyelinating polyneuropathy
CIS carcinoma in situ
CKD chronic kidney disease
CLL chronic lymphocytic leukemia
CML chronic myeloid leukemia
COPD chronic obstructive pulmonary disease
COVID-19 coronavirus disease 2019
CRC colorectal cancer
CRS cytokine release syndrome
CSCC cutaneous squamous cell carcinoma
CV cardiovascular
CVD cardiovascular disease
CYP cytochrome P450
DMD Duchenne muscular dystrophy
dMMR deficient mismatch repair
DR delayed release
EGFR epidermal growth factor receptor
ER extended release
ER+ estrogen receptor-positive
ERBB2 erythroblastic oncogene B receptor 2
ERC enhanced removal capability
ESR1 estrogen receptor 1
FGFR3 fibroblast growth factor receptor 3
FLOT fluorouracil, leucovorin, oxaliplatin and docetaxel
GERD gastroesophageal reflux disease
GEJ gastroesophageal junction
GVHD graft versus host disease
HABP hospital-acquired bacterial pneumonia
HCC hepatocellular carcinoma
HCI hydrochloride
HeFH heterozygous familial hypercholesterolemia
HER2 human epidermal growth factor receptor 2
HER2+ human epidermal growth factor receptor 2-positive
HER2- human epidermal growth factor receptor 2-negative
HF heart failure
HIV-1 human immunodeficiency virus type-1
HNSCC head and neck squamous cell cancer
HoFH homozygous familial hypercholesterolemia
HR hormone receptor
HR+ hormone receptor-positive
HSCT hematopoietic stem cell transplant
HTN hypertension
IBS-C irritable bowel syndrome with constipation
IDH isocitrate dehydrogenase
Ig immunoglobulin
IHC immunohistochemistry
IM intramuscular
IR Immediate-release
ISH in situ hybridization
IV intravenous
KMT2A lysine methyltransferase 2A gene
KRAS Kirsten rat sarcoma virus
LDL-C low-density lipoprotein cholesterol
LEPR leptin receptor
LRTD lower respiratory tract disease
LVEF left ventricular ejection fraction
LVH left ventricular hypertrophy
MACE major adverse cardiovascular events
MASH metabolic dysfunction-associated steatohepatitis
MCC Merkel cell carcinoma
MDS myelodysplastic syndrome
mFOLFOX6 fluorouracil, leucovorin, oxaliplatin
MI myocardial infarction
MPM malignant pleural mesothelioma
MSI-H microsatellite instability-high
MuSK muscle-specific tyrosine kinase
NPM1 nucleophosmin 1
NRG1+ neuregulin 1-positive
NSCLC non-small cell lung cancer
NTRK neurotrophic tyrosine receptor kinase
ODT orally disintegrating tablet
PAH pulmonary arterial hypertension
PCSK1 proprotein convertase subtilisin/kexin type 1
PD-L1+ programmed death-ligand 1-positive
Ph+ Philadelphia chromosome-positive
Ph- Philadelphia chromosome-negative
PIK3CA phosphatidylinositol-3-kinase catalytic subunit alpha
PKU phenylketonuria
POMC pro-opiomelanocortin
PrEP pre-exposure prophylaxis
PsA psoriatic arthritis
PsO plaque psoriasis
R/R relapsed or refractory
RCC renal cell carcinoma
RET rearranged during transfection
RNA ribonucleic acid
RSV respiratory syncytial virus
RVO retinal vein occlusion
SC subcutaneous
SCLC small cell lung cancer
sJIA systemic juvenile idiopathic arthritis
SLL small lymphocytic leukemia
SMN1 survival motor neuron 1
T2DM type 2 diabetes mellitus
TMB-H tumor mutational burden-high
TNBC triple-negative breast cancer
TKD tyrosine kinase domain
UTI urinary tract infection
VABP ventilator-associated bacterial pneumonia
VEGF vascular endothelial growth factor
VRd bortezomib, lenalidomide, dexamethasone
VTE venous thromboembolism
XR extended release
*Disclaimer: Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer.
All brand names are property of their respective owners.