FDA Approves the First Gene-Editing Treatment for Sickle Cell Disease

The treatment, called Casgevy, is developed by Vertex Pharmaceuticals and CRISPR Therapeutics. It affects approximately 100,000 people in the United States, the majority of whom are Black. The first signs of the disease usually show up within the first year of life. vchal / Getty Images This is a cure. How Does the Treatment Work? The patient must then undergo chemotherapy before the edited stem cells can be inserted back into the patient....

April 18, 2025 · 1 min · 187 words · Aaron Johnson

FDA Approves the First Interchangeable Biosimilar for Humira

Cyltezo is expected to be more affordable than Humira, which can cost up to $9,000 a month. Biologic drugs like Humira are often more costly because production requires living organisms. An interchangeable biosimilar provides greater access and affordability for patients in need of these products, Bernstein tells Verywell. Lara Antal / Verywell Cyltezo will be available only by prescription. It is injected subcutaneously, just under the skin. Dosage varies, depending on the condition for which the drug is being used....

April 18, 2025 · 1 min · 176 words · Nicole Woods

FDA Authorizes a New COVID-19 Monoclonal Antibody Drug From Eli Lilly

With the emergence of variants such as Omicron, treatment options remain limited. The U.S. government agreed to purchase up to 600,000 doses of bebtelovimab for at least $720 million. But they are not a substitute for vaccination against COVID-19. Cristina Arias / Getty Images Being vaccinated is still the best way to protect yourself and others. Lillys prior monoclonal antibody formulation was a mixture of two drugs called bamlanivimab and etesevimab....

April 18, 2025 · 1 min · 194 words · Crystal Phillips

FDA Authorizes COVID-19 Vaccines for Children as Young as 6 Months

So far, all states besides Florida have preordered vaccines for young children. For the youngest kids: Additionally, the FDA authorized Moderna’s vaccine forchildren aged 6 through 17. Throughout the pandemic, roughly one in four children required ICU admission. Verywell / Photo Illustration by Laura Porter / Getty Images This means Moderna recipients may need three shots to be fully protected and Pfizer vaccinees may eventually need four. The manufacturers each tested several dose sizes to minimize the risk of fever and other side effects in kids....

April 18, 2025 · 2 min · 375 words · Christine King

FDA Authorizes Updated Moderna and Pfizer Booster Shots

A panel of CDC advisers will meet on September 1 and 2 to discuss the clinical considerations. Will Bivalent Boosters Offer Long-term Protection? Of people who have received the full COVID-19 primary series, fewer than half have gotten their first booster. Verywell Health / Tara Anand Only about a third of adults older than 50 have received their second booster. For Moderna, the age requirement is 18 and above. For the most recent updates on COVID-19, visit ourcoronavirus news page....

April 18, 2025 · 1 min · 104 words · Kelsey King

FDA Clears the First Implantable Continuous Glucose Monitor That Can Last a Year

The previous monitor, Eversense E3, couldlast up to six months without replacement. The approval of Eversense 365 represents a significant leap in CGM innovation. Heres what else you oughta know about how CGMs work, potential risks, and where to get it. Photo Illustration by Amelia Manley for Verywell Health; Senseonics & Ascensia Diabetes Care How Does Eversense 365 Work? How Accurate Is the Eversense CGM? Do you better Do Fingersticks If You Use a CGM?...

April 18, 2025 · 1 min · 192 words · Tanya Moore

FDA Delays Decision on COVID Vaccine for Kids Under 5

Ellen Lindner / Verywell Key Takeaways Parents of young kids nationwide recently received some disappointing news. That age group is the only one for whom the Pfizer vaccine is not yet authorized. (Moderna and Johnson and Johnsons COVID-19 vaccines are authorized for people 18 and older. Both companies are still studying pediatric doses.) Why Exactly Was It Delayed? Each dose had a tenth of the amount in an adult dose....

April 18, 2025 · 2 min · 230 words · Danielle Miles

FDA Grants Full Approval to Pfizer COVID-19 Vaccine

The shot will be marketed under the new name Comirnaty. The approval is currently designated for people age 16 and older. It allows for Pfizer to communicate with advertisers and healthcare providers directly. Drew Angerer / Getty Images “The moment you’ve been waiting for is here.” There is a pervasive narrativethat is untrueabout how this is somehow an experimental vaccine, Wen tells Verywell. Once theres full approval, you’ve taken away that particular argument....

April 18, 2025 · 2 min · 254 words · Andrea Davis

FDA Greenlights a Second RSV Vaccine for Older Adults

So having some vaccines available for the prevention of RSV in older persons, is really a great advance. The single-dose vaccine works by blocking a key protein that helps the virus to invade human cells. These serious adverse events were rare, representing one case for every 9,000 participants. Luis Alvarez / Getty Images However, thats higher than the one to two people per 100,000 typically diagnosed with Guillain-Barre each year....

April 18, 2025 · 1 min · 203 words · Patricia Vasquez

FDA Recommends Booster Shots for Omicron Subvariants

Based on reported data, the vaccines demonstrated slightly different levels of effectiveness against Omicron. The company said it will continue to collect more data to adapt its formulations to emerging sublineages if necessary. When Will The New Boosters Become Available? Verywell Health / Tara Anand Both vaccine manufacturers shared their data with regulators in late June. For the most recent updates on COVID-19, visit ourcoronavirus news page. Centers for Disease Control and Prevention....

April 18, 2025 · 1 min · 75 words · Jessica Morrow

FDA Revokes Authorization for the Only Remaining COVID-19 Monoclonal Antibody Treatment

Eli Lilly, the manufacturer of bebtelovimab, has stopped distributing the antibody treatment, the FDA said. The evolution of COVID-19has already rendered many monoclonal antibody treatments ineffective. The bebtelovimab news marks the removal of yet another tool from the arsenal to defend against COVID-19. Juan Gaertner / Science Photo Library / Getty Images It is not a surprising move. Neutralizing antibody levels were low to undetectable against BQ.1.1 four months after boosting....

April 18, 2025 · 2 min · 220 words · Stephanie Rose

FDA Says Popular Prescription Lice Treatment Can Be Sold Over-the-Counter

Prescription lice treatment can be hard to get and some OTC treatments arent very effective. This will make Sklice more accessible for patient care. When a child has lice, they might have to stay home from school until the treatment is successful. Richard Bailey / Getty Images Nits will look like small white or yellow-brown specks and be firmly attached to the hair near the scalp. Nits can be confused with dandruff, dirt particles, or hair spray droplets....

April 18, 2025 · 2 min · 335 words · Cassandra Hernandez

FDA-Approved Hepatitis C Drugs

The remaining mainstays of hepatitis C treatment are listed by the order of their FDA approval. Mavyret is effective at clearing all six hepatitis C genotypes in as little of eight weeks. The recommended dosage is three tablets taken once daily with food. Courtesy of Abbvie The recommended dosage is one tablet one pill taken once daily with food for 12 weeks. The average wholesale price (AWP) of Vosevi is $74,760 for a 12-week course....

April 18, 2025 · 2 min · 250 words · Eric Bennett