May 05, 2025

FDA Monthly Round-up: Key April Updates

April’s FDA approvals feature first-in-class therapies, targeted biologics, expanded indications, and innovative delivery systems across allergy, endocrinology, rheumatology, oncology, infectious diseases, and more.

Conexiant

April 25, 2025

FDA Approves Penpulimab-kcqx for NPC

The FDA approved penpulimab-kcqx for first line and previously treated recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.

Conexiant

April 24, 2025

WHI Funding Cuts Threaten Research Continuity

HHS will terminate WHI Regional Center funding in September 2025.

Conexiant

April 23, 2025

FDA Targets Petroleum-Based Dyes in Food Supply

The FDA and HHS announced plans to eliminate petroleum-based synthetic food dyes, citing potential health risks and aligning with global safety standards.

Conexiant

April 17, 2025

Oral Agent Shows Weight, A1c Drops

“As a convenient once-daily pill, orforglipron may provide a new option”—Lilly's oral GLP-1 agent showed up to 7.9% weight loss and HbA1c reductions in phase III diabetes trial.

Reuters

April 11, 2025

FDA Clears Longest Lasting CGM

Dexcom G7 15 Day receives FDA clearance, offering adults with diabetes the longest lasting and most accurate continuous glucose monitoring system to date.

Conexiant

June 12, 2024

USPSTF Releases Draft Osteoporosis Screening Guidelines

The USPSTF's draft recommendations reaffirm osteoporosis screening for older women, call for more research on screening men, and address health disparities.

Conexiant

August 01, 2024

Tirzepatide Reduces Heart Failure Risk by 38% in Clinical Trial

Results from a trial reveal that Eli Lilly's tirzepatide, a weight loss drug, reduces the risk of heart failure outcomes by 38% compared to a placebo for obese adults, with significant weight loss and improved symptoms. Novo Nordisk's Wegovy also shows promise in reducing heart failure symptoms.

Reuters

September 09, 2024

FDA Lifts Hold on Low Blood Sugar Treatment

Rezolute Inc has received FDA approval to proceed with its late-stage trial for a new treatment addressing low blood sugar in individuals with congenital hyperinsulinism, with potential U.S. enrollment expected to start in early 2025.

Reuters