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Even Five Years Postapproval, Many Drug Studies Remain Nonpublic

Authors urge greater transparency of study results for drugs approved by the FDA

Certain Tests for Pregnancy, Ovulation, UTIs Should Not Be Used, FDA Warns

A variety of tests for pregnancy, ovulation, urine, and breast milk should not be used because of concerns over efficacy and safety

FDA Orders Stores to Stop Selling Elf Bar Disposable Vapes

Disposable e-cigarettes are sold in flavors known to appeal to children and teenagers, including bubblegum and cotton candy

Chinese Company May Help Ease U.S. Shortage of Cancer Drug

When importing drugs, the FDA stressed that regulators carefully assess product quality and manufacturing processes to ensure patient safety

FDA Approves Xacduro for Difficult-to-Treat Bacterial Pneumonia

Approval is for hospital-acquired bacterial or ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii-calcoaceticus complex

FDA Clears New Insulin Pump and Algorithm-Based Software

Enhanced automatic insulin delivery system cleared for people with type 1 diabetes ≥6 years

FDA Approves New Nasal Spray to Reverse Overdoses

To be sold as Opvee, the spray contains the medication nalmefene hydrochloride and will be available with a prescription

Epkinly Granted Accelerated FDA Approval for Lymphoma

Approved for use in relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma

FDA Approves First Nonhormonal Drug to Ease Menopause Hot Flashes

Veozah targets the neurokinin 3 receptor, which is linked to the regulation of body temperature

FDA Advisers OK Approval of First Over-the-Counter Birth Control Pill

AMA, AAFP, ACOG, and other medical organizations already support OTC access to hormonal contraception without age restrictions