FDA Approval — Regulatory Intelligence | Humanexa Signals

CompetitiveJune 17, 2026

Overview of Antibody-Drug Conjugates in Cancer Therapy and Clinical Development

Antibody-drug conjugates (ADCs) have shown significant clinical benefits in advanced phase trials for various cancers, with over a dozen receiving FDA approval.

Recent events(38)

FDA Approves Supplement for Fluorescite by Alcon Labs

FDA Approves ANDA for Valacyclovir Hydrochloride by Hetero Labs

Aurobindo Pharma's Cephalexin Receives FDA Approval

Historical activity(13)

Ionis Pharmaceuticals — Donidalorsen

Biogen — Leqembi

— Argatroban

— Fosaprepitant Dimeglumine

— Pipeline Update

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FDA Approves Supplemental Application for Capecitabine by Accord Healthcare

FDA Approves ANDA for Tofacitinib Citrate by Auson

FDA Approves Linezolid in Sodium Chloride 0.9% for Hospira

FDA Approves Supplemental Applications for ZYVOX by Pfizer

FDA Approves Supplement for Vancomycin Hydrochloride in Plastic Container

FDA Approves Supplement for Estradiol by Mylan Technologies

FDA Approves Albuterol Sulfate ANDA219409 from Cipla

FDA Approves OTC Naloxone Nasal Spray Rextovy for Opioid Overdose

FDA Approves Hydroxyzine Hydrochloride ANDA220271 by Saptalis Pharmaceuticals

FDA Approves ANDA216272 for Norepinephrine Bitartrate by Nephron

FDA Approves First Generic of Xofluza for Influenza Treatment

FDA Approves First Oral Carbapenem for Complicated UTIs

FDA Approves CAPVAXIVE for At-Risk Children and Adolescents

FDA Approves Supplemental Application for REXTOVY by Amphastar Pharmaceuticals

Cipla's ANDA214209 for Sumatriptan Receives Abbreviated Approval from FDA

FDA Approval Update for Divalproex Sodium by Mylan

FDA Approves Supplemental Application for Zyrtec Hives by Kenvue Brands

FDA Approves Supplement for INQOVI (NDA 212576) by Taiho Oncology

FDA Approves Merck’s IDVYNSO for Virologically Suppressed HIV-1 Patients

Overview of Antibody-Drug Conjugates in Cancer Therapy and Clinical Development

Merck Receives FDA Approval for IDVYNSO, Expands Oncology Pipeline and Animal Health Sales

FDA Approves Bizengri for NRG1 Fusion-Positive Cholangiocarcinoma

FDA Approves Tzield for Pediatric Patients with Stage 3 Type 1 Diabetes

FDA approves Lilly's EBGLYSS® for atopic dermatitis with unique dosing regimen

Saphnelo Self-Administration Approved in the US for SLE Treatment

Enhertu Gains FDA Approval for Two New HER2+ Early Breast Cancer Indications

FDA Approves KEYTRUDA Combinations for Adjuvant Treatment in Clear Cell RCC

Roche's VENTANA PTEN Assay Receives FDA Approval for Prostate Cancer Companion Diagnostic

FDA Approves Pfizer’s HYMPAVZI for Expanded Hemophilia A and B Indications

FDA Approval Status Update for Lidocaine Hydrochloride 0.4% in Dextrose 5%

FDA Approval Process Update for Mycophenolate Mofetil by Strides Pharma

FDA Approves Supplement for Methylprednisolone Acetate by Sandoz

FDA Approval Status Update for Losartan Potassium by Micro Labs

FDA Approves Deflazacort Supplement Application by Upsher Smith Labs

FDA Approves Supplement for Levetiracetam by Chartwell RX

TARO Pharmaceuticals — PERAMPANEL

Roche — Kadcyla

AstraZeneca — Truqap

Roche —

AstraZeneca — Camizestrant

Roche —

Merck — KEYTRUDA

AstraZeneca — Enhertu