Type 1 Diabetes Mellitus

• FDA approval · 2026-08-11
  FDA Approved: METFORMIN HYDROCHLORIDE ORAL SOLUTION — Supplemental Application (TRUPHARMA, LLC)

  Supplemental application approval for Metformin Hydrochloride Oral Solution by Trupharm a, LLC to support a new or revised formulation and/o…

• FDA approval · 2026-04-20
  FDA Approved: TZIELD — Supplemental Application (Provention Bio, Inc.)

  The FDA approved a supplemental application for TZIELD (teplizumab-mzwv) from Provention Bio, Inc.

• EMA approval · 2026-04-17
  EMA Authorised: Teizeild (teplizumab) — Sanofi Winthrop Industrie

  The European Medicines Agency authorised Teizeild (teplizumab) from Sanofi Winthrop Industrie for the treatment of Type 1 diabetes mellitus.

• EMA approval · 2025-11-14
  First-in-class treatment to delay onset of type 1 diabetes

  EMA has approved Teizeild, a first-in-class therapy that delays the onset of stage 3 type 1 diabetes. The treatment also helps preserve insu…

• FDA approval · 2025-05-07
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for insulin lispro from Eli Lilly and Company.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2024-11-25
  FDA Approved: INSULIN GLARGINE — Supplemental Application (Biocon Biologics Inc.)

  FDA approved a supplemental application for INSULIN GLARGINE-YFGN from Biocon Biologics Inc., authorizing its biosimilar insulin glargine pr…

• CLINICAL_TRIALS approval · 2024-10-22
  Clinical Trial Update: Islet Transplantation in Type I Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol

  The trial update indicates that islet transplantation using the UIC protocol by CellTrans has received marketing approval for Type 1 diabete…

• FDA approval · 2024-08-29
  FDA Approved: TOUJEO — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approves a supplemental application for Toujeo (insulin glargine) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2024-08-09
  FDA Approved: REZVOGLAR KWIKPEN — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Rezvoglar KwikPen (insulin glargine-AGLR) from Eli Lilly and Company.

• FDA approval · 2023-11-29
  FDA Approved: INSULIN GLARGINE — Supplemental Application (Biocon Biologics Inc.)

  FDA approved Biocon Biologics' supplemental application for INSULIN GLARGINE-YFGN (insulin glargine).

• FDA approval · 2023-07-21
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  FDA approves a supplemental application for insulin lispro submitted by Eli Lilly and Company.

• FDA approval · 2023-07-21
  FDA Approved: HUMALOG MIX50/50 KWIKPEN — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Humalog Mix50/50 KwikPen (insulin lispro) from Eli Lilly and Company. Insulin lispro is used…

• FDA approval · 2023-07-21
  FDA Approved: HUMALOG KWIKPEN — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for HUMALOG KWIKPEN (insulin lispro) from Eli Lilly and Company.

• FDA approval · 2023-07-21
  FDA Approved: HUMALOG MIX75/25 — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for HUMALOG MIX75/25 (insulin lispro) from Eli Lilly and Company.

• FDA approval · 2023-06-29
  FDA Approved: LANTUS SOLOSTAR — Supplemental Application (sanofi-aventis U.S. LLC)

  The FDA approved a supplemental application for Lantus SoloStar (insulin glargine) from sanofi-aventis U.S. LLC. This notice confirms regula…

• FDA approval · 2023-05-30
  FDA Approved: INSULIN GLARGINE — Supplemental Application (Biocon Biologics Inc.)

  FDA approved Biocon Biologics Inc.'s supplemental Biologics License Application for insulin glargine-YFGN, a biosimilar insulin glargine pro…

• FDA approval · 2023-05-26
  FDA Approved: INPEFA — Original Application (Lexicon Pharmaceuticals, Inc.)

  FDA approved the original application for INPEFA (sotagliflozin) by Lexicon Pharmaceuticals.

• FDA approval · 2023-02-28
  FDA Approved: NOVOLOG — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for NovoLog (insulin aspart) filed by Novo Nordisk.

• FDA approval · 2023-02-28
  FDA Approved: INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 — Supplemental Application (Novo Nordisk Pharma, Inc.)

  FDA approved a supplemental application for the insulin aspart protamine and insulin aspart mix 70/30 product (brand NovoLOG Mix 70/30) from…

• FDA approval · 2023-02-03
  FDA Approved: AFREZZA — Supplemental Application (Mannkind Corporation)

  The FDA approved a supplemental application for AFREZZA (insulin human) from MannKind Corporation.

• FDA approval · 2022-12-08
  FDA Approved: LEVEMIR — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for LEVEMIR (insulin detemir) from Novo Nordisk, resulting in labeling changes related to the pr…

• FDA approval · 2022-11-30
  FDA Approved: APIDRA — Supplemental Application (sanofi-aventis U.S. LLC)

  FDA approved a supplemental application for APIDRA (insulin glulisine) filed by Sanofi‑Aventis U.S. LLC.

• FDA approval · 2022-11-23
  FDA Approved: NOVOLIN 70/30 — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for NOVOLIN 70/30 (human insulin) from Novo Nordisk.

• FDA approval · 2022-11-17
  FDA Approved: TZIELD — Original Application (Provention Bio, Inc.)

  The FDA approved TZIELD (teplizumab-mzwv) in an original Biologics License Application to delay the onset of stage 3 type 1 diabetes in indi…

• FDA approval · 2022-11-16
  FDA Approved: REZVOGLAR KWIKPEN — Original Application (Eli Lilly and Company)

  FDA approved Rezvoglar KwikPEN (insulin glargine-AGLR) from Eli Lilly as a biosimilar insulin glargine via an Original Application. It is in…