From FDA approvals streamlining access to critical therapies to new breakthroughs in challenging malignancies, the field of cancer care continues to demonstrate remarkable progress.

Agency will require a Limitation of Use section in the prescribing information of all extended-release ADHD stimulants.

Opinion: Orrick's Irena Royzman and Dana Sublett write that judges have done a good job in multiple decisions that protect ...

Onward Medical announced today that it submitted its ARC-EX system for expanded FDA indication and for CE mark approval.

The FDA has accepted Aquestive Therapeutics’ new drug application for its Anaphylm sublingual epinephrine film for treating ...

Introduction to the New Prescription Drug Labeling by the Food and Drug Administration Renu Lal; Mary Kremzner Disclosures Am J Health Syst Pharm. 2007;64 (23):2488-2494. 0 ...

FRIDAY, June 20, 2025 (HealthDay News) — A new shot to prevent HIV infection has just been approved — and it only needs to be taken twice a year. On Wednesday, the U.S. Food and Drug ...

The open-label, randomized, no-treatment controlled trial included 40 adult patients diagnosed with AKU (ClinicalTrials.gov Identifier: NCT00107783).

The committee members said they were reaffirming “the essential role FDA plays in determining the safety of food and color additives in the nation’s food and beverage supply.” They also requested that ...

Steel asked. “Absolutely not,” Paul said. Steel followed up: What was a drug mule? “Someone who trafficks kilos and kilos of drugs around the world,” Paul said matter-of-factly.

Key Takeaways The FDA approved updated labeling for Talzenna plus Xtandi for HRR gene-mutated metastatic castration-resistant prostate cancer, based on the TALAPRO-2 trial results. The TALAPRO-2 trial ...