Ryan Livingston

The FDA accepted Bayer’s sNDA for finerenone in adults with type 1 diabetes and CKD based on albuminuria data from FINE-ONE.

Retatrutide successfully reduced body weight versus placebo in adults with obesity or overweight in topline phase 3 TRIUMPH-1 results.

FDA granted priority review to asundexian for secondary prevention after non-cardioembolic ischemic stroke or TIA.

FDA approved baxdrostat as add-on therapy for adults with hypertension not controlled on other medications.

The FDA has cleared the EndoTool IV Cloud for hospital IV insulin dosing support, expanding Glooko’s inpatient platform via the 510(k) pathway.

The NDA submission follows positive results from the CALIBRATE phase 3 trial, which evaluated encaleret versus standard-of-care in adults with ADH1.

This FDA News Month in Review provides a round-up of regulatory decisions from April 2026.

Patient education may be the missing piece needed to bridge the gap between hypertension treatments and improved outcomes.

The new recommendations outline glucocorticoid tapering strategies for adults and children with classic CAH after starting crinecerfont.

Catch up on key clinician insights, major FDA decisions, groundbreaking trial results, and more.

Catch up on any data and perspectives presented at the American Association of Clinical Endocrinology Annual Meeting 2026.

April 2026 saw further updates from ACC.26, plus key trial results, guideline updates, and more.

The FDA granted Fast Track Designation to coramitug, an investigational anti-TTR antibody designed to clear existing amyloid deposits in ATTR cardiomyopathy.

FDA cleared Control-IQ+ for pregnancy in type 1 diabetes, expanding automated insulin delivery options during gestation.

Recent data presented at AACE 2026 have indicated the efficacy of GLP-1 RA treatment in reducing risk of diabetic retinopathy, renal disease, and others.

A recent study presented at AACE 2026 has displayed the IGF-1R’s capacity for improving proptosis and disease activity in patients with poorly-controlled TED.

A recent presentation at AACE 2026 highlights the drastically increased risk of mortality, sepsis, diabetic ketoacidosis, and recurrent acute pancreatitis after GLP-1 initiation.

A recent study from AACE 2026 has indicated the value of bariatric surgery in adults with type 1 diabetes – and emphasized the need for closer perioperative management.

Results from the largest and longest trial of orforglipron to date have displayed the drug’s efficacy in reducing all-cause cardiovascular death and MACE incidence.

Although the approval does not permit entrance into the market, this decision marks an important step to more universally accessible GLP-1 RAs.

Catch up on FDA decisions, new GLP-1 agonists, and more.

Catch up on major trial results, groundbreaking guideline updates, and more.

Catch up on data from some of the most impactful trials presented at the American College of Cardiology 2026.

Amgen has announced positive topline results from their phase 3 trial comparing teprotumumab-trbw – administered via an on-body injector – to placebo.

Catch up on the most impactful trial readouts to come out of ACC 2026.

The FDA has issued its third CRL to topical ocular reproxalap for the treatment of signs and symptoms of dry eye disease.

Data from the ACCESS II trial, ACCESS extension study, and a body composition study provide an early look at efficacy and safety data of a new investigational oral GLP-1.

Bialo discusses her perspective on the importance of T1D screening and its capacity to reduce the risk of disease progression and eventual complications later in life.

Catch up with FDA decisions, key trial results, podcast updates, and more.

Catch up with FDA decisions, key trial results, and more.