FDA News Month in Review: January 2025

Published Date: 06 Feb 2025

This FDA News Month in Review provides a round-up of regulatory decisions and submissions from January 2025.

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Latest News

Bayer Says FDA Grants Priority Review Designation for Finerenone

Bayer said on Thursday ⁠that the U.S. Food and ⁠Drug Administration had accepted its ⁠supplemental New ‌Drug Application for finerenone and granted priority review...

BioMarin's Drug Shows Significant Growth Gains in Children in Late-stage Trial

BioMarin Pharmaceutical said on Wednesday its treatment for a rare condition that ⁠leads to short stature helped boost growth in children, meeting the main goal of a...

Diabetic Peripheral Neuropathy Tied to Dementia Risk in T2D

Diabetic peripheral neuropathy above a certain vibration perception threshold is linked to a notably higher risk for dementia in patients with type 2 diabetes, according to a Danish cohort study.

Finding the Next Weight-Loss Drug in Python Blood

Pythons can go weeks without eating. Now researchers have isolated an appetite-suppressing metabolite in python blood that could spur a new weight-loss therapy.

Diabetes Meds Show Varied Associations With Liver Protection

Different antidiabetic drug classes show distinct associations with the risk for major adverse liver outcomes among patients with type 2 diabetes, according to a network meta-analysis.

Could Digital Obesity Care Help Improve the Economy?

A UK digital obesity programme was associated with > 40% fewer GP visits and markedly lower long-term sick leave within 9 months in a real-world analysis.

Todays Updates

EMA Backs Breast Cancer SERD After FDA No Vote

The recommendation follows phase 3 data showing longer progression-free survival when patients switched to camizestrant plus a CDK4/6 inhibitor.

Datopotamab Deruxtecan Earns New Breast Cancer Indication

The antibody drug conjugate was approved by the FDA for certain patients with triple-negative breast cancer.

Todays Updates

EMA Backs Breast Cancer SERD After FDA No Vote

The recommendation follows phase 3 data showing longer progression-free survival when patients switched to camizestrant plus a CDK4/6 inhibitor.

Datopotamab Deruxtecan Earns New Breast Cancer Indication

The antibody drug conjugate was approved by the FDA for certain patients with triple-negative breast cancer.

Latest News

Bayer said on Thursday ⁠that the U.S. Food and ⁠Drug Administration had accepted its ⁠supplemental New ‌Drug Application for finerenone and granted priority review...

BioMarin Pharmaceutical said on Wednesday its treatment for a rare condition that ⁠leads to short stature helped boost growth in children, meeting the main goal of a...

Diabetic peripheral neuropathy above a certain vibration perception threshold is linked to a notably higher risk for dementia in patients with type 2 diabetes, according to a Danish cohort study.

Pythons can go weeks without eating. Now researchers have isolated an appetite-suppressing metabolite in python blood that could spur a new weight-loss therapy.

Different antidiabetic drug classes show distinct associations with the risk for major adverse liver outcomes among patients with type 2 diabetes, according to a network meta-analysis.

A UK digital obesity programme was associated with > 40% fewer GP visits and markedly lower long-term sick leave within 9 months in a real-world analysis.

News All Time

Acute Kidney Injury Sets Kids Up for Chronic Kidney Disease

A meta-analysis finds increased long-term odds of chronic kidney disease and death in children who survive acute kidney injury.

Cotrimoxazole Tied to More AEs in Older Men With UTIs

The use of cotrimoxazole is linked to about twice the risk of developing adverse events compared with the use of fluoroquinolones among older men with UTIs.

GLP-1 RAs May Independently Boost Testosterone Levels

Increases in testosterone were realized in a large cohort regardless of patient age or BMI at baseline and could not be explained just by weight loss.

New Dosing Option Okayed for X-Linked Hypophosphatemia Drug

The FDA has approved an option to increase the dose and frequency of burosumab-twza for adults whose serum phosphorus remains below normal.

BioMarin's Genetic Disease Therapy Shows Mixed Results in Late-stage Study

BioMarin Pharmaceutical said on Monday its experimental treatment for a rare genetic condition met ⁠one of the two main goals in a late-stage study.

Many Parents on Obesity Meds Discuss Treatment With Kids

Parents often discuss using obesity medications and related weight or behavior changes with their children.

Menopause Symptoms Worse in Women With Abdominal Obesity

Women with abdominal obesity report a higher burden of certain menopausal symptoms and exhibit a distinct pattern of symptom interrelationships relative to women without abdominal obesity.

Can Lower-Dose Tirzepatide Keep Weight Off?

New trial data suggest some patients may maintain meaningful weight loss after stepping down from the maximum dose of tirzepatide.

Pesticides May Help Explain Rising Early-Onset CRC Rates

A study linked a common herbicide to rising early-onset colorectal cancer, using DNA methylation to trace lifelong exposures rather than relying on patient recall.

Restarting GLP-1s After Stopping: How to Counsel Patients

Many patients taking GLP-1 RAs for weight loss discontinue within the first year. How can clinicians support long-term success with these drugs?

Exclusive-FDA Drug Center Head Expected to Leave After Commissioner's Exit, Sources Say

The acting head of the U.S. Food and Drug Administration's drug center, Tracey Beth Hoeg, is expected to leave the agency just days after Commissioner Marty ⁠Makary...

Implanted Islet Cell Device Could Control Glucose for Weeks

Researchers developed a battery-free device the size of a coin that can deliver islet cells in the body and keep them healthy, no immunosuppression required.

US Cancer Clinics Scramble to Get Experimental Revolution Medicines Pancreatic Cancer Drug

U.S. cancer centers are scrambling to enroll patients in an early access program for a highly promising pancreatic cancer drug from Revolution Medicines while they await...

Blame for the Obesity Epidemic Falls on Food Industry

The rise of new weight-loss drugs could help reframe obesity as a societal failure driven by the food industry, rather than an individual failing rooted in lack of willpower.

Can GLP-1 Drugs Improve Breast Cancer Survival?

A ‘big’ data study links the diabetes and weight-loss drugs to better long-term survival after breast cancer. Critics are unconvinced.

EyePoint's Late-stage Eye Drug Trials to Continue After Safety Panel Review

EyePoint said on Thursday an independent safety committee found no new concerns in two late-stage trials ⁠of its experimental eye disease drug Duravyu and recommended the...

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"We Caught It Early": Advantage or Disadvantage?

From 40 to 74, the US Preventive Services Task Force advises every two years for screening mammography.

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