Key Takeaways On May 26, 2021, the Food and Drug Administration (FDA) approved Myfembree as the first once-daily treatment for heavy menstrual bleeding that is associated withuterine fibroids. As of June 17, 2021, the medication is available to patients in the U.S. with a physician’s referral. Uterine fibroids do not always cause symptoms. When they do, the heavy bleeding andpelvic painthat they can cause can greatly affect a person’s quality of life....

Key TakeawaysMany older adults with acute myeloid leukemia (AML) cannot receive traditional aggressive chemotherapy treatment because of its toxicity.The U.S. Food and Drug Administration (FDA) has approved the use of a new drug in combination with one of the standard treatments for AML.The new therapy can be an option for AML patients who are unable to receive intensive chemo. Key Takeaways Many older adults with acute myeloid leukemia (AML) cannot receive traditional aggressive chemotherapy treatment because of its toxicity....

Key Takeaways The U.S. Food and Drug Administration (FDA) approved a new implant that can repair some anterior cruciate ligament (ACL) injuries. The FDA granted marketing authorization for an implant to repair the injury. The Bridge-Enhanced ACL Repair (BEAR) Implant is an alternative to ACL reconstruction, which typically requires harvesting tendons—and sometimes bone—from another part of the patient’s body or a deceased donor. It can also be done via sutures, a medical device used to hold body tissues together....

Key TakeawaysThe FDA has approved the first birth control pill available over the counter.The Opill has been on the market for 50 years and evidence shows that it’s safe and effective. Key Takeaways The FDA has approved the first birth control pill available over the counter.The Opill has been on the market for 50 years and evidence shows that it’s safe and effective. A birth control pill will soon be available for salewithout a prescription in the United States....

Key Takeaways The Food and Drug Administration (FDA) approved Veklury (remdesivir) for the treatment of COVID-19 in hospitalized patients 12 and older on Thursday. This is the first officially FDA-approved drug for COVID-19. Although the drug is now approved, the approval does not extend to all groups. Patients must weigh at least 40 kilograms (kg)—about 88 pounds—to receive remdesivir. In an effort to continue to offer the drug to pediatric patients covered under the first EUA when necessary, the FDA has reissuedanotherEUA for remdesiver use in:...

Key TakeawaysThe FDA has approved Saphnelo (anifrolumab) to treat moderate to severe lupus in individuals who are already receiving standard treatment for the disease.The recommended dosage of Saphenelo is 300 mg, administered as an intravenous infusion over a 30-minute period, every 4 weeks.Saphenlo is considered safe for most patients; however, it can increase the risk for viral respiratory infections and shingles. Key Takeaways The FDA has approved Saphnelo (anifrolumab) to treat moderate to severe lupus in individuals who are already receiving standard treatment for the disease....

Key Takeaways The Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa) to treat moderate to severe ulcerative colitis in adults.This approval expands upon Skyrizi’s previous approvals for other inflammatory diseases, including plaque psoriasis, psoriatic arthritis, andCrohn’s disease. Ulcerative colitisis a chronic inflammatory bowel disease (IBD) that causes inflammation and ulcers on the inner lining of the large intestine, resulting in symptoms like diarrhea, abdominal pain, and increased stool frequency. It affects approximately 600,000 to 900,000 people in the U....

Key Takeaways The Food and Drug Administration (FDA) last week approved Skyrizi (risankizumab-rzaa) to treatCrohn’s disease, a type of inflammatory bowel disease (IBD). Skyrizi uses a unique mechanism that may alleviate symptoms such as diarrhea and abdominal pain, even in patients who don’t respond well to other treatments. Skyrizi is the first interleukin-23 inhibitor licensed for Crohn’s—an approach that has long seemed promising for tamping autoimmune disorders. It is the first treatment licensed for Crohn’s disease in six years, according to AbbVie....

Key TakeawaysThe FDA approved a fecal transplant therapy that can reduce the recurrence ofC. diffinfection in adults.This is the first approval for fecal transplant therapy in the United States.Other products to treat diseases of the microbiome could follow close behind. Key Takeaways The FDA approved a fecal transplant therapy that can reduce the recurrence ofC. diffinfection in adults.This is the first approval for fecal transplant therapy in the United States.Other products to treat diseases of the microbiome could follow close behind....

Key TakeawaysThe Food and Drug Administration has approved Cyltezo, an interchangeable biosimilar of Humira (adalimumab)There are other biosimilars of Humira, but Cyltezo is the first that is also interchangeable, which means that pharmacists can substitute it for Humira in some states.Cyltezo is expected to cost less than Humira, but the price has not been set as yet, and it will not be marketed until July 2023 due to patent protection on Humira....

Key TakeawaysThe FDA approved a new treatment for uncontrolled high blood pressure.The once-daily oral medication, called Tryvio (aprocitentan), is expected to be available in the second half of 2024.Tryvio is approved for use in combination other antihypertensive medications. Key Takeaways The FDA approved a new treatment for uncontrolled high blood pressure.The once-daily oral medication, called Tryvio (aprocitentan), is expected to be available in the second half of 2024.Tryvio is approved for use in combination other antihypertensive medications....

Key TakeawaysFor the first time in 20 years, the FDA has approved a nonstimulant drug to treat adults with ADHD.It was long assumed that most children may outgrow the condition, but many don’t, though it may present differently in adults.The approval opens up more non-addictive treatment options for adults with ADHD. Key Takeaways For the first time in 20 years, the FDA has approved a nonstimulant drug to treat adults with ADHD....

Key TakeawaysThe FDA approved Takeda’s Eohilia, the first and only oral medication for the treatment of EoE.EoE is an inflammatory condition in the esophagus. When inflammation worsens, it can cause trouble and pain while swallowing or eating.Before Eohilia’s approval, Dupixent was the only other FDA-approved treatment option for people with EoE. Key Takeaways The FDA approved Takeda’s Eohilia, the first and only oral medication for the treatment of EoE.EoE is an inflammatory condition in the esophagus....