REGULATORYRFK Jr.: 14 peptides returning to Category 1 — FDA advisory committee July 2026UPDATESemaglutide and tirzepatide compounding ended — shortage resolved Feb/May 2025REGULATORYBPC-157, TB-500, thymosin alpha-1, CJC-1295, ipamorelin: expected Category 1 reclassification pendingFDAFDA advisory committee meetings scheduled: late July 2026RESEARCHA Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature [NCT06382155]RESEARCHMetabolic Effects of Angiotensin-(1-7) [NCT02646475]RESEARCHEvaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder [NCT06651177]RESEARCHMulti-Site Trial of Tirzepatide for Smoking Cessation [NCT07602699]RESEARCHA Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide [NCT06897475]RESEARCHTranslational Health Research Into Vascular and Neurocognitive Effects of Weight Loss [NCT07592546]RESEARCHTirzepatide in the Treatment of Endometrial Cancer [NCT07605247]RESEARCHA Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes During Ramadan [NCT06635057]RESEARCHA Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes) [NCT07165028]NEWSOorja, run by Acceleron veterans, launches to make new fibrosis drugsREGULATORYRFK Jr.: 14 peptides returning to Category 1 — FDA advisory committee July 2026UPDATESemaglutide and tirzepatide compounding ended — shortage resolved Feb/May 2025REGULATORYBPC-157, TB-500, thymosin alpha-1, CJC-1295, ipamorelin: expected Category 1 reclassification pendingFDAFDA advisory committee meetings scheduled: late July 2026RESEARCHA Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature [NCT06382155]RESEARCHMetabolic Effects of Angiotensin-(1-7) [NCT02646475]RESEARCHEvaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder [NCT06651177]RESEARCHMulti-Site Trial of Tirzepatide for Smoking Cessation [NCT07602699]RESEARCHA Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide [NCT06897475]RESEARCHTranslational Health Research Into Vascular and Neurocognitive Effects of Weight Loss [NCT07592546]RESEARCHTirzepatide in the Treatment of Endometrial Cancer [NCT07605247]RESEARCHA Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes During Ramadan [NCT06635057]RESEARCHA Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes) [NCT07165028]NEWSOorja, run by Acceleron veterans, launches to make new fibrosis drugs

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FDA Drugs

Bydureon BCise

Exenatide Extended Release

FDA Approved
SUBCUTANEOUS INJECTIONExenatide Extended Release
Approved 2012NDA022200GLP-1 AgonistNDC 0310-6548-12

Manufacturer

AstraZeneca

1 MedImmune Way, Gaithersburg MD 20878

Indication

Type 2 diabetes

Notes

2mg weekly autoinjector

NDC Codes (1)

NDC CodeStrengthDosage FormPackage
0310-6548-122mg/0.65mLExtended-release suspension4 pens

FDA Manufacturers

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Regulatory Updates

Latest FDA regulatory news

Data Source: Prescribing data sourced from openFDA drug labeling database. This is for informational purposes only and is not medical advice.