EPA Imposes New Limit on Medical Sterilization Chemical, Citing Cancer Risk
The Environmental Protection Agency (EPA) issued a final rule on Thursday that aims to markedly reduce cancer risks for those living near commercial sterilization facilities by lowering toxic emission standards for ethylene oxide. Ethylene oxide, the most commonly used sterilant for medical devices in the U.S., is used for everything from wound dressings to endoscopes […]
Drug Candidate for Chronic Cough Rejected by FDA Panel
FDA advisors told the agency that the current evidence does not support approval of gefapixant for chronic cough, a condition where no approved therapy exists. On Friday, members of the Pulmonary-Allergy Drugs Advisory Committee voted 12-1 that the small reductions in cough frequency demonstrated in phase III trials of the P2X3 receptor antagonist do not […]
Tirzepatide Wins FDA Approval for Weight Loss
The FDA approved tirzepatide (Zepbound), the latest injectable for chronic weight management in adults, the agency announced on Wednesday. The combination glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist is indicated for adults with obesity or overweight with at least one weight-related condition, alongside a reduced-calorie diet and increased physical activity. Eli Lilly’s […]
What To Do If You Feel Traumatized By The Latest Mass Shooting
Anadolu Agency via Getty Images A view of the street while police officers close the road as they patrol around the street during inspection after a gunman’s multiple shootings in Maine on October 26, 2023. At least 22 people have been reportedly killed and as many as 60 wounded after a gunman went on a […]
FDA OKs First Pill for Postpartum Depression
The FDA approved zuranolone (Zurzuvae) as the first oral treatment for postpartum depression, the agency announced late on Friday. Until now, brexanolone (Zulresso) has been the only other treatment with an indication for postpartum depression, but that drug requires a continuous IV infusion administered by a healthcare provider. “Postpartum depression is a serious and potentially […]
First Drug Approved for Kids’ Functional Constipation
The FDA approved linaclotide (Linzess) capsules for treating functional constipation in kids 6 years and up, the agency announced on Monday. Along with data from trials in adults with chronic idiopathic constipation, support for the pediatric approval came from a phase III trial that included 330 children and adolescents ages 6 to 17 years with […]
All Thumbs Up for OTC Birth Control Pill at FDA Advisory Meeting
In a unanimous vote, advisors to the FDA recommended the agency approve what could become the first-ever over the counter (OTC) birth control pill. All 17 members of the joint Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee said the widespread benefits of switching daily norgestrel tablets 0.075 mg (Opill) […]
FDA Panel Rejects Broad Olaparib Indication in Metastatic CRPC
In a near-unanimous vote on Friday, outside advisors to the FDA recommended a narrow indication should the agency approve olaparib (Lynparza) plus abiraterone (Zytiga) as initial treatment for metastatic castration-resistant prostate cancer (mCRPC). In an 11-1 vote (with one abstention), the Oncologic Drugs Advisory Committee (ODAC) recommended that any approval be restricted to patients with […]
FDA Panel Backs Full Approval of Paxlovid for COVID-19
An FDA panel recommended the agency grant full approval to nirmatrelvir-ritonavir (Paxlovid) for treating high-risk COVID-19. By a vote of 16-1 on Thursday, the Antimicrobial Drugs Advisory Committee said the totality of evidence supports the traditional approval of the oral antiviral, which has been widely used since late 2021 under an emergency use authorization to […]
Second RSV Vaccine for Older Adults Gets Thumbs Up From FDA Advisors
A panel of FDA’s outside advisors recommended the agency approve GSK’s respiratory syncytial virus (RSV) vaccine for older adults, a day after backing Pfizer’s RSV vaccine candidate for that same population. By votes of 12-0 on efficacy and 10-2 on safety, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) said the available data support […]