The latest headlines across every section, pulled from official and open-access sources.
An Elevance Health Public Policy Institute study found rural patients used telehealth less than non-rural patients across all chronic conditions and insurance types. The post Report: Telehealth Uptake Is Lagging in Rural Areas appeared first on MedCity News .
PHILADELPHIA, August 3, 2026—Obesity is a serious, complex condition that has wide-ranging health and system-wide effects that must be addressed with consideration to clinical and environmental factors, says the American College of Physicians (ACP). In a new paper, “Public Policy Approaches to Addressing Adult Obesity: A Position Paper from the American College of Physicians ” published today in Annals of Internal Medicine , ACP offers recommendations on how policymakers can increase accessibility of obesity treatment for adults and address modifiable factors that contribute to obesity…
M&A activity is going beyond big pharma acquisitions with Supernus Pharmaceuticals and Indivior Pharmaceuticals reaching a stock deal that the companies call a merger of equals. The combined company’s portfolio will have 11 commercialized products in addiction, attention-deficit hyperactivity disorder, depression, and Parkinson’s disease. The post Supernus and Indivior to Merge, Forming a New CNS-Focused Pharma Company appeared first on MedCity News .
Publications from Office of Biostatistics Staff
Quality Information for Applicants | Chemistry, Manufacturing, and Controls (NDAs, ANDAs, BLAs, and IND applications)
FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs.
Immune checkpoint inhibitors (ICIs) are revolutionary oncologic therapies used frontline in several malignant neoplasms, including non–small cell lung cancer, melanoma, renal cell carcinoma, bladder cancer, and colorectal cancer.
There are three types of submissions needed to register an establishment and list a drug with FDA. Learn more.
There is wide variation in antithrombotic regimens after valve-in-valve (ViV) TAVR and no significant differences in outcomes, according to a study published July 27 in JACC: Cardiovascular Interventions.
Establishments, with certain exemptions, engaged in manufacturing, repacking, relabeling or salvaging drugs for U.S. distribution is required to register with FDA.
Labeler codes are used to propose and assign national drug codes (NDCs) for drugs and are required prior to listing a drug or reserving an NDC with FDA for the first time. Learn more.
Reserving a national drug code is an optional step that provides an NDC up to two years before a drug is ready to launch. Learn more.
All registered establishments must list every drug they produce for U.S. commercial distribution under their own labeler code. Learn more.
FOR IMMEDIATE RELEASE – July 31, 2026 – Shirley, NY, American Regent, Inc. Animal Health is conducting a nationwide recall of two lots (25011 and 3369) of Adequan® Canine Injection (for dogs), 100 mg/mL 5mL multi-dose vials and two lots (24416 and 25265P) of Adequan® i.m. Injection (for horses), 500
Integer expects to gain flexibility and capital to invest in its contract development and manufacturing business under KKR.
Despite remarkable advances in cardiovascular medicine, persistent disparities continue to limit patient access to care. Three recent Viewpoints published in JACC: Advances argue that achieving equitable health outcomes will require a stronger focus on digital health connectivity, intentional implementation of evidence-based care, and long-term strategies that address social drivers of health across the lifespan.
The company disclosed the appointment of João Seabra the day before cutting its full-year sales outlook in response to continued challenges at its diagnostics division.
by Angeliki Apostolou, Reuben Simfukwe, Adrias Saint, Bridget Mushani, Hannah Chekhchar, Pearl Aovare, Kouamivi M. Agboyibor, Karlijn A. C. Meeks, George F. Mkoma, Charles Agyemang, Felix P. Chilunga Background Type 2 diabetes and hypertension are major public health challenges in sub-Saharan Africa, yet treatment control remains poor. Patient adherence to key treatment pillars (medication, lifestyle advice, and self-monitoring) is essential for treatment control, yet adherence across these pillars has not been comprehensively synthesized. We conducted a systematic review and meta-analysis to…
by Junjie Lin, Mika Kivimäki, Zifan Zhang, Hui Wang, Yangyang Cheng, Xiaolin Xu Background Impairments in physical, psychological, and cognitive functioning are associated with an increased risk of falls. However, how these functional domains change longitudinally before and after fall events remains unclear. We examined individual and joint trajectories of these outcomes preceding and following falls. Methods and findings Using data collected between 2010 and 2021 from three national cohorts in China, the UK, and the USA, we included 28,773 adults aged ≥60 years and performed 1:1 matching…
Months after reports first linked Curium to a potential Lantheus takeover, the radiopharma players have made it official with a deal worth up to $8 billion.
Ethical AI and trustworthy AI frameworks should be table stakes for healthcare and life sciences organizations seeking to innovate with AI. The post From Ethics to Trust: Strategic Guardrails for Safe, Secure, Effective AI in Healthcare appeared first on MedCity News .
In collaboration with industry and the public, FDA creates an annual list of regulatory science initiatives on generic drugs.
Boticelli Foods of Melville NY, is recalling 1 lot of bettergoods Pistachio Nut Butter, NET WT 6.7oz (190g), UPC 194346207961, Lot LB028ACP04, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail
The products that succeed over time are usually the ones that make life easier, fit naturally into existing routines and continue delivering value long after the novelty wears off. The post Beyond Adoption: The Habits Shaping Digital Health appeared first on MedCity News .