The FDA has issued a second complete response letter to Atara Biotherapeutics for its biologics license application of tabelecleucel for adults and children with Epstein-Barr virus-positive post-transplant lymphoproliferative disease.
The company had submitted the application for Ebvallo (tabelecleucel) — an off-the-shelf allogeneic Epstein-Barr virus-specific cytotoxic T-cell therapy — as monotherapy for affected adult and pediatric patients aged 2 years and older who had received at least one prior therapy, including an anti-CD20 containing regimen.
The FDA wrote that it is unable to approve

It’s Friday afternoon when the question comes in:
“What antibiotic should I use to treat this patient’s Klebsiella pneumoniae? It’s resistant to carbapenems, and there’s a comment from microbiology that says ‘carbapenemase production detected.’ Oh, and it looks like it’s resistant to ceftazidime-avibactam, too.”
Carbapenem resistance can be mediated by carbapenemases, which include both serine beta-lactamases (eg, Klebsiella pneumoniae carbapenemase [KPC] and oxacillinase-48 [OXA-48]) and metallo-beta-lactamases (MBL; eg, New Delhi metallo-beta-lactamase [NDM]). Infections due to

Wow. I mean, just wow. Am I really that old?
All I can think of as I sit down to share my annual New Year’s resolutions with you is that it seems like it was only a month ago that I was writing my 2025 list. You know, time flies and all. Maybe it is because the Healio | OSN columnists submit their January articles in advance and it is not really January as I write this. Still, I think I am starting to really dislike whoever it was who said that time moves faster as you get older.
Any faster and it will soon be yesterday!
Anyhow, here I sit, once again, reviewing last year’s resolutions and

WAIKOLOA, Hawaii — At Orthopedics Today Hawaii, Rachel M. Frank, MD, shared surgical pearls for osteochondral allograft transplantation.
“What we really want to make sure is that we’re getting perpendicular to the defect site. So, you have to make sure your drilling is exactly perpendicular or you're off a little bit. If you get it right the first time with your drilling, you’re going to be really good for getting that graft into the recipient socket,” Frank, associate professor in the Department of Orthopedic Surgery and director of the Joint Preservation Program

WAIKOLOA, Hawaii — At Orthopedics Today Hawaii, Hollis G. Potter, MD, shared her pearls for the assessment of MRIs used in the management of knee sports medicine injuries.
Potter, chair of the department of radiology and imaging at Hospital for Special Surgery, said it is important to check posterolateral corner injuries in the assessment of the ACL.
“You’ll see a little signal. It doesn't necessarily mean that you do a reconstruction,” she said. “Always correlate with your [examination under anesthesia (EUA)]. Think about the mechanics as you look for a bone

The American College of Cardiology issued its inaugural JACC Cardiovascular Statistics report, highlighting the prevalence of 10 CVDs and risk factors and trends in quality of care and mortality associated with them.
Drawn from national surveys, registries and administrative data, the report, published in the Journal of the American College of Cardiology, outlines the prevalence, treatment and impact on mortality from five CV risk factors — hypertension, diabetes, obesity, LDL cholesterol and cigarette smoking — and five diseases — coronary heart disease, acute MI, heart failure, peripheral

WAIKOLOA, Hawaii — Adam B. Yanke, MD, PhD, spoke about different indications for surgery for patients with patellar instability at Orthopedics Today Hawaii, here.
“One of the most important things is that if you’re going to do patellar surgery, doing a [medial patellofemoral ligament (MPFL)] reconstruction correctly is the most important aspect because a well-done surgery with just a ligament can help the vast majority of patients — at least 90% of them,” Yanke, associate professor of orthopedics and assistant director of the Cartilage Restoration Center at Rush

Incorporating weight-loss interventions improved psoriasis severity and quality of life for patients with overweight or obesity, according to a systematic review and meta-analysis.
Approximately 80% of the 60 million people worldwide with psoriasis have overweight or obesity, researchers wrote in the Journal of the European Academy of Dermatology & Venerology. Excess weight can increase psoriasis severity, impact quality of life and reduce efficacy of available therapies.
“In dermatology clinics, people with psoriasis increasingly ask what they can do beyond medication to manage their skin

Omidenepag isopropyl led to significant IOP reductions that were sustained over the course of 5 years in patients with glaucoma, according to a study published in Cureus.
The results suggest that omidenepag isopropyl ophthalmic solution 0.002%, known as Omlonti (Ocuvex Therapeutics) in the United States, could be a reliable treatment for glaucoma that avoids the cosmetic side effects of prostaglandin analogs.
“Chronic exposure to prostaglandin agonists commonly induces prostaglandin-associated periorbitopathy, a condition involving various periocular changes such as deepening of the upper

Editor’s note: This is a developing news story. Please check back soon for updates.
The FDA has cleared a mobile application that will connect with a next-generation multiple daily injection automated insulin delivery system, according to an industry press release.
Medtronic Diabetes announced that the FDA has granted 510(k) clearance for the MiniMed Go app for children and adults aged 7 years or older with type 1 or type 2 diabetes who require insulin as well as children aged 2 to 6 years with diabetes under supervision of an adult caregiver.
According to the press release, the app will connect