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calendar

12 catalysts · 18,987 approval · 5,159 phase readout · 5,000 device 510k · 4,728 grant · 2,516 8k filing · 2,000 device pma

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type: patent expiry×type: adcom×clear all
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  • approval18,987
  • phase readout5,159
  • device 510k5,000
  • grant4,728
  • 8k filing2,516
  • device pma2,000
device recall
2,000
  • recall1,126
  • device adverse event1,000
  • pdufa319
  • therapy area
    • Infectious Disease9
    • Oncology2
    • Dermatology1
    • Pulmonology1

    Week of Apr 20, 2026

    4
    ›Apr 24, 2026patent expiry97d agoDaiichi Sankyo Co Ltd — laninamivir (Constraining Patent Expiry (Japan))laninamivir

    Therapy area: Infectious Disease, Respiratory. Indication: Asthma, Influenzavirus A Infections, Influenzavirus B Infections

    full page →laninamivir →source: globaldata
    ›Apr 24, 2026patent expiry97d agoEisai Co Ltd — lenvatinib mesylate (Constraining Patent Expiry (US))lenvatinib mesylate

    Therapy area: Gastrointestinal, Infectious Disease, Oncology. Indication: Acral Lentiginous Melanoma, Adenocarcinoma Of The Gastroesophageal Junction, Adenoid Cystic Carcinoma (ACC), Adrenocortical Carcinoma (Adrenal Cortex Cancer), Anaplastic Thyroid Cancer, Bile Duct Cancer (Cholangiocarcinoma), Bladder Cancer, Breast Cancer, Colorectal Cancer, Cutaneous Squamous Cell Carcinoma (cSCC), Endometrial Cancer, Ependymoma, Epithelial Ovarian Cancer, Esophageal Squamous Cell Carcinoma (ESCC), Ewing S

    full page →lenvatinib mesylate →source: globaldata
    ›Apr 25, 2026patent expiry96d agoStemline Therapeutics Inc — SL-901 (Constraining Patent Expiry (Japan))SL-901

    Therapy area: Oncology, Undisclosed. Indication: Lung Cancer, Solid Tumor, Unspecified Rare Disease

    full page →SL-901 →source: globaldata
    ›Apr 26, 2026patent expiry95d agoBlue Blood Biotech Corp — BB-101 (Constraining Patent Expiry (Japan))BB-101

    Therapy area: Dermatology. Indication: Diabetic Foot Ulcers

    full page →BB-101 →source: globaldata

    Week of Apr 27, 2026

    7
    ›Apr 27, 2026patent expiry94d agoBill & Melinda Gates Medical Research Institute — SB-692342 (Constraining Patent Expiry (Japan))SB-692342

    Therapy area: Infectious Disease. Indication: Pulmonary Tuberculosis

    full page →SB-692342 →source: globaldata
    ›Apr 28, 2026patent expiry

    Week of Jul 27, 2026

    1
    ›07/29/2026adcom1d agoAdvisory Committee Calendar

    This page contains notices of advisory committee meetings. Refer to the individual meeting link below for more information on the anticipated format of each meeting. For previous years' advisory committee calendars, see the FDA Archive.

    full page →fda adcom ↗
    93d ago
    GSK plc — dolutegravir sodium ODT (Constraining Patent Expiry (Japan))dolutegravir sodium

    Therapy area: Infectious Disease. Indication: Human Immunodeficiency Virus (HIV) Infections (AIDS)

    full page →dolutegravir sodium →source: globaldata
    ›Apr 28, 2026patent expiry93d agoGSK plc — (abacavir sulfate + dolutegravir sodium+ lamivudine) ODT (Constraining Patent Expiry (Japan))(abacavir sulfate + dolutegravir sodium + lamivudine)

    Therapy area: Infectious Disease. Indication: Human Immunodeficiency Virus (HIV) Infections (AIDS)

    full page →(abacavir sulfate + dolutegravir sodium + lamivudine) →source: globaldata
    ›Apr 28, 2026patent expiry93d agoGSK plc — cabotegravir sodium (Constraining Patent Expiry (US))cabotegravir sodium

    Therapy area: Infectious Disease. Indication: Human Immunodeficiency Virus (HIV) Infections (AIDS)

    full page →cabotegravir sodium →source: globaldata
    ›Apr 28, 2026patent expiry93d agoViiV Healthcare UK Ltd — cabotegravir + rilpivirine LA (Constraining Patent Expiry (US))cabotegravir + rilpivirine LA

    Therapy area: Infectious Disease. Indication: Human Immunodeficiency Virus (HIV) Infections (AIDS)

    full page →cabotegravir + rilpivirine LA →source: globaldata
    ›Apr 28, 2026patent expiry93d agoViiV Healthcare UK Ltd — cabotegravir LA (Constraining Patent Expiry (US))cabotegravir LA

    Therapy area: Infectious Disease. Indication: Human Immunodeficiency Virus (HIV) Infections (AIDS)

    full page →cabotegravir LA →source: globaldata
    ›Apr 30, 2026patent expiry91d agoBasilea Pharmaceutica Ltd — isavuconazonium sulfate (Constraining Patent Expiry (US))isavuconazonium sulfate

    Therapy area: Infectious Disease. Indication: Aspergillosis, Candidiasis, Cryptococcal Meningitis, Cryptococcosis, Zygomycosis (Mucormycosis)

    full page →isavuconazonium sulfate →source: globaldata
    $GSK53.22-0.91%
    $GSK53.22-0.91%
    $GSK53.22-0.91%