Tag: Food & Drug Administration
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
FDA Approves First Pill for Fecal Transplant Therapy
Vowst is approved to prevent recurrence of C. difficile; pill contains live gut bacteria from stool samples donated by healthy people
FDA Approves Drug for Rare Form of ALS
Agency approved the drug based on evidence of a reduction in plasma neurofilament light; no evidence the drug slowed the disease
FDA Withdraws Approval of Drug Meant to Prevent Preterm Births
Agency has formally withdrawn the approval of Makena over a lack of effectiveness and serious side effects that include blood clots, depression
