article thumbnail

FDA Approves Nitisinone for Treatment of Alkaptonuria

Drug Topics

The FDA approved nitisinone (Harliku) for the reduction of urine homogentisic acid (HGA) in patients with alkaptonuria (AKU). The FDA approved nitisinone (Harliku) for the reduction of urine homogentisic acid (HGA) in patients with alkaptonuria (AKU). The medication is expected to launch in July 2025. REFERENCES 1.

FDA 341
article thumbnail

FDA Approves Widaplik for Treatment of Hypertension

Drug Topics

The FDA approved telmisartan, amlodipine and indapamide (Widaplik) for the treatment of hypertension in adult patients, George Medicines said in a release. The FDA approved telmisartan, amlodipine and indapamide (Widaplik) for the treatment of hypertension in adult patients, George Medicines said in a release. References 1.

FDA 281
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA to speed reviews for drugs supporting ‘national interests’

PharmaVoice

A new pilot program announced by FDA Commissioner Dr. Martin Makary would award vouchers that could cut drug reviews to one or two months — but only for products that meet a special criteria.

FDA 219
article thumbnail

FDA Roundup: Biosimilar Approval, Hereditary Angioedema Treatment Receives Orphan Drug Designation

Drug Topics

Check out important updates from the FDA for the week of September 30.

FDA 503
article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. What will the future hold for clinical research?

article thumbnail

FDA Expands OA REMS, Mandates Mail-Back Envelopes for Opioid Analgesics

Drug Topics

The FDA has mandated that companies participating in the Opioid Analgesic Risk Evaluation and Mitigation Strategy program provide pre-paid mail-back envelopes for unused or expired opioid medications.

FDA 503
article thumbnail

FDA Approves Tirzepatide for Obstructive Sleep Apnea in Patients with Obesity

Drug Topics

Zepbound from Eli Lilly is the first and only prescription medicine approved by the FDA for adults with obstructive sleep apnea and obesity.

FDA 467