CDC ENTEBBE

The FDA approved Cologuard Plus, a multitarget stool DNA test for colorectal cancer detection in adults aged 45+, based on BLUE-C study data showing higher sensitivity than an independent fecal immunochemical test. Exact Sciences plans to launch with Medicare coverage in 2025.

FDA approves at-home use of FluMist nasal spray flu vaccine, available from fall 2025 for ages 2-49, aiming to increase vaccination rates and address needle phobia.

31 of 54 African countries had medical device clinical trials (MDCTs) on clinicaltrials.gov. Northern Africa had the most MDCTs, with Egypt leading. Central Africa had the fewest MDCTs. Health conditions varied by region, with Northern Africa focusing on non-communicable diseases and neurodegenerative conditions, while Southern and Eastern Africa concentrated on HIV/AIDS and malaria. Half of all MDCTs were completed, with Western and Central Africa having the most completed trials. Funding varied, with most MDCTs funded by non-US bodies. Trial duration differed by region, with Southern and Western Africa having longer median durations. The primary purpose of devices under trial was mostly treatment, with significant focus on oral and skeletal health issues.

FDA approves Fresenius Kabi’s and Formycon’s Otulfi, a biosimilar to Stelara, for treating Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks Fresenius Kabi’s fourth biosimilar approval by the FDA, aligning with its Vision 2026 strategy to expand its biopharma market presence.

An NIEHS-supported study by Million Marker and University of Nevada researchers aimed to reduce participants' exposure to endocrine-disrupting chemicals (EDCs) through improved environmental health literacy. Participants' EDC levels were measured via urinalysis, and personalized reports detailing health effects and exposure reduction methods were provided. The study, published in July 2024, found that participants successfully used the information to reduce EDC exposure, with notable reductions in phthalates detected in urine samples post-intervention.

60 Degrees Pharmaceuticals, Inc. launches a nine-month pilot to boost ARAKODA® (tafenoquine) awareness and usage via virtual sales and a co-pay program. ARAKODA is the only new antimalarial in over a decade, offering broad efficacy, weekly dosing, and a safe profile. The pilot aims to gather insights for a 2025 U.S. sales expansion.

NIAID's HIV research aims to maintain core discovery, address HIV intersections with other diseases, compress trial timelines, respond to implementation science, leverage partnerships, close pandemic gaps, and plan for rapid impact by 2034.

Pfizer withdraws Oxbryta, its sickle cell disease therapy, from worldwide markets due to higher risk of deaths and complications, leaving patients and doctors seeking alternatives.

FDA approved FluMist nasal spray flu vaccine for ages 2-49, available online for home administration, aiming to boost declining vaccination rates. FluMist, initially approved in 2003, is now self-administered or by a caregiver, potentially capturing those avoiding shots due to needle fear or scheduling issues. Common side effects include runny nose, nasal congestion, and sore throat. Not approved for adults 50+, as immune systems weaken with age, necessitating high-dose vaccines for seniors.

Oregon State University researchers, funded by a $1.2 million NIH grant, aim to develop a personalized medicine device for epilepsy patients using saliva analysis and AI to optimize anti-seizure drug dosing.