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FDA Daily

FDA daily for Monday, September 7, 2026

155 FDA records across 3 sections. 8 touch MedGrid's categories and are listed first.

155FDA Records
3 of 7Sections With Data
8Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Sun, Sep 6 (yesterday)
Nothing from FDA for this date
Drug approvalsCovers FDA's Mon, Aug 31 (a week ago)
25
  • BAVENCIO

    AVELUMAB — EMD SERONO INC

    BLA761049 · Labeling

  • POMALIDOMIDE

    POMALIDOMIDE — SPIL

    ANDA210232 · Original approval

  • FLUDEOXYGLUCOSE F18

    FLUDEOXYGLUCOSE F-18 — PETNET

    ANDA079086 · Manufacturing (CMC)

  • FENOFIBRIC ACID

    CHOLINE FENOFIBRATE — RISING

    ANDA211626 · Labeling

  • EPLERENONE

    EPLERENONE — SANDOZ

    ANDA078510 · Labeling

  • FEXOFENADINE HYDROCHLORIDE

    FEXOFENADINE HYDROCHLORIDE — AUROBINDO PHARMA LTD

    ANDA213466 · Manufacturing (CMC)

  • IMFINZI

    DURVALUMAB — ASTRAZENECA UK LTD

    BLA761069 · Labeling

  • TRANEXAMIC ACID

    TRANEXAMIC ACID — MICRO LABS

    ANDA206713 · Labeling

  • YERVOY

    IPILIMUMAB — BRISTOL MYERS SQUIBB

    BLA125377 · Labeling

  • LIBTAYO

    CEMIPLIMAB-RWLC — REGENERON PHARMACEUTICALS

    BLA761097 · Labeling

  • CEFAZOLIN IN DEXTROSE

    CEFAZOLIN SODIUM — BAXTER HLTHCARE CORP

    NDA207131 · Labeling

  • TERIFLUNOMIDE

    TERIFLUNOMIDE — SANDOZ

    ANDA209710 · Labeling

Showing 12 of 25. Search the rest in openFDA.

Drug recallsCovers FDA's Mon, Aug 31 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Mon, Aug 31 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Mon, Aug 31 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Mon, Aug 24 (two weeks ago)
7
  • TiLink-L™ SI Joint Fusion System

    SurGenTec, LLC

    K261381 · Substantially Equivalent · Orthopedic

  • Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 9…

    Sonoscape Medical Corp.

    K254027 · Substantially Equivalent · Radiology

  • BiWaze Clear System

    Abmrc, LLC

    K260604 · Substantially Equivalent · Anesthesiology

  • OsteoCoil™ GT Active Compression System

    Flower Orthopedics Corporation DBA Conventus Flower Orthoped

    K260106 · Substantially Equivalent · Orthopedic

  • SEISMIQ™ Intravascular Lithotripsy System

    Bolt Medical, Inc.

    K260246 · Substantially Equivalent · Cardiovascular

  • Guided Bone Regeneration System

    DentalMaster(Xiamen)Medical Technology Co., Ltd.

    K254286 · Substantially Equivalent · Dental

  • Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments

    Biomet Orthopedics, Inc.

    K253515 · Substantially Equivalent · Orthopedic

Label changesCovers FDA's Mon, Aug 24 (two weeks ago)
8 touch MedGrid123
  • PROGESTERONETouches MedGrid categories

    Preferred Pharmaceuticals Inc.

    Label version 3

  • Exuviance Age Reverse Day Repair with Sunscreen Broad Spectrum SPF 30Touches MedGrid categories

    NeoStrata Company Inc.

    Label version 8

  • Bovonte Numbing CreamTouches MedGrid categories

    Guangzhou Jingliang Cosmetics Co., Ltd.

    Label version 2

  • HEEL PAIN RELIEF ROLL-ONTouches MedGrid categories

    Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.

    Label version 1

  • KNEE PAIN RELIEF ROLL-ONTouches MedGrid categories

    Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.

    Label version 1

  • Big Toe Joint Pain Relief PatchTouches MedGrid categories

    Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.

    Label version 1

  • SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01Touches MedGrid categories

    Cosmuses Cosmetics (Ningbo) Co., Ltd.

    Label version 1

  • GynobalanceTouches MedGrid categories

    BioActive Nutritional, Inc.

    Label version 6

  • Hylands Naturals Earache Drops

    Hyland's Inc.

    Label version 7

  • Magnesium Sulfate in Dextrose

    Hospira, Inc.

    Label version 33

  • DOXEPIN HYDROCHLORIDE

    REMEDYREPACK INC.

    Label version 1

  • Medline

    Medline Industries, LP

    Label version 3

Showing 12 of 123. Search the rest in openFDA.

How the FDA Daily Is WrittenSources, dates and what gets flagged

Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug recalls, device recalls and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Items that touch the categories MedGrid works in, such as GLP-1s, hormones, injectables, peptides, compounded products and aesthetic devices, are marked and listed first.

Subscribe with any feed reader, or point an email tool at theRSS feed. For the rules behind the headlines, see Regulations Research.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.