Tag: Food & Drug Administration
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
