SPOTLIGHT -
FDA, CDC Increase Availability of RSV Monoclonal Antibody for Infants
The federal agencies said that they will continue to work closely with manufacturers to maintain the availability of the vaccines through the end of 2023 and early 2024 to meet the demand during the RSV season.
Delta-8 THC Accessibility, Marketing to Minors Cause for Concern
Unlike traditional THC, which is federally banned, D8 has managed to find a legal loophole, making it widely accessible.
Pitocin in Late Stage Labor May Help Reduce Rates of Obstetrical Hemorrhage
Implementing a standardized oxytocin infusion protocol may increase patient safety while reducing maternal adverse effects that are associated with rapid, high rates of infusion of oxytocin.
FDA Approves Scoliosis Treatment For Young Patients
The REFLECT Scoliosis Correction System from Globus Medical is intended to correct progressive scoliosis in pediatric patients while simultaneously maintaining stability and motion as well as allowing for future modulated growth.
FDA Officially Withdraws Approval of Makena After Lengthy Debate
The FDA has finally decided to withdraw approval of Makena and its generics after Covis Pharma volunteered to remove the drug from market in March.
Fezolinetant Appears Successful In Treating Hot Flashes And Night Sweats
Results from a phase 3 study show that the drug is effective in treating VMS symptoms due to menopause.
FDA Accepts Biologics License Application for Proposed Denosumab Biosimilar
The drug, manufactured by Sandoz, will treat conditions including osteoporosis in postmenopausal women
Azithromycin Reduces Risk of Maternal Sepsis, Death in Vaginal Delivery
A single oral dose of azithromycin during labor in women planning vaginal delivery can significantly reduce the risk of maternal sepsis or death
BLA for Sandoz Proposed Denosumab Biosimilar Accepted by FDA
The Biologics License Application of a proposed biosimilar of denosumab, a drug that could treat several bone diseases and issues, has been accepted by the FDA.
Evaluating Chronic Itch and Quality of Life
Several factors predict itch-specific quality of life in patients with chronic itch.
Accelerated Approval to Mirvetuximab Soravtansine-gynx Granted by FDA
This is the first FDA-approved ADC for platinum-resistant disease, according to ImmunoGen.
Poor Sleep in Premenopausal and Perimenopausal Women Linked to Migraine History
History of migraine may be associated with poor sleep in premenopausal and perimenopausal women, according to research presented at the North American Menopause Society Annual Meeting.
FDA Gives OK to Pediatric Use of Monkeypox Vaccine
The FDA has granted Emergency Use Authorization EUA of the Jynneos vaccine for pediatric patients <18 years who are at high risk of monkeypox infection.
Myfembree Approved by FDA for Treating Endometrial Pain
Myovant Sciences and Pfizer announces the FDA has approved the therapy for the once-daily treatment of moderate-to-severe endometriosis-associated pain.
Perrigo Submits Application to FDA for First-ever OTC Birth Control Pill
Perrigo’s HRA Pharma has submitted an application to the FDA for possible future approval of the first-ever OTC birth control pill.
FDA: First Drug Approved for Recurrent Vulvovaginal Candidiasis
Oteseconazole (Vivjoa) reduces the incidence of recurrent vulvovaginal candidiasis.
Encourage Pregnant Patients to Get Vaccinated for COVID-19, ACOG Says
"The spread of misinformation and mistrust in doctors and science is contributing to staggeringly low vaccination rates among pregnant people," said the American Colleges of Obstetricians and Gynecologists.
Potential Carcinogens Detected in Several Sunscreen Products
A recent test found various brands and batches of sunscreen and after-sun care products contained benzene, a potential carcinogen.
COVID-19 Vaccine Recipients Experiencing Delayed 'Vaccine Arm' Reaction
Increasing reports have surfaced of vaccine recipients experiencing delayed cutaneous side effects after receiving the first dose.
