The latest headlines across every section, pulled from official and open-access sources.
This cross-sectional study investigates the geographic distribution and accessibility of clinical trials of systemic treatments for invasive fungal infections.
This randomized clinical trial compares the effectiveness and safety of topical antiseptic regimens to reduce bacterial load in the maternal genital tract and on neonatal skin for prevention of sepsis in low-income countries.
This cohort study examines waterborne transmission of Mycobacterium abscessus by whole-genome sequencing isolates from patients and health care environmental reservoirs and determining the genetic relatedness of the isolates.
This cohort study examines characteristics of artificial intelligence (AI)–enabled medical devices, including clinical study evidence, associated with US Food and Drug Administration (FDA) recall.
This qualitative study of parents of children with medical complexity explores how parents’ lived caregiving experiences shape their orientations toward life-sustaining treatment in their children.
The Digital Medicine Society launched an initiative to help payers and virtual care providers avoid common contract implementation challenges. The post DiMe Launches New Initiative for Virtual-First Care appeared first on MedCity News .
Government invests in artificial intelligence (AI) technologies to modernise the NHS and reduce waiting times.
Discover potential signals of serious risks and new safety information identified by the FDA's Adverse Event Monitoring System (AEMS). Learn how the FDA monitors and evaluates drugs for safety concerns, providing important updates on adverse events to protect public health.
During a panel at HFMA’s annual conference, two healthcare credit analysts said the industry is already fracturing into winners and losers. And with 2030 bringing a perfect storm of demographic pressure, reimbursement cuts and AI disruption, they think window for bold action is closing fast. The post ‘2030 Scares Me to Death’: Credit Analysts’ Urgent Warning for Healthcare CFOs appeared first on MedCity News .
On September 20, 2024, FDA requested Azurity Pharmaceuticals Inc. stop distributing unapproved drugs marketed as “Unit-of-Use Prescription Compounding Kits.
The Food and Drug Administration is advising consumers not to purchase or use Business Pill, a product promoted and sold for male sexual enhancement on various websites, including https://supplx.com, and possibly in some retail stores.
The Food and Drug Administration is advising consumers not to purchase or use Branch Manager for Men, a product promoted and sold for male sexual enhancement on various websites, including https://supplx.com, and possibly in some retail stores.
Adoption of the GammaTile radiotherapy implant is growing, the company said, and the new funding round validates its potential to be a standard of care treatment.
Parabilis Medicines is developing a new type of peptide drug capable of hitting elusive disease targets inside cells. Cancer is the biotech’s initial focus, and the IPO cash will support lead program zolucatetide, which is in development for a rare type of tumor with limited treatment options. The post Parabilis Medicines’ Quest to Drug the Undruggable Picks Up $745M From Upsized IPO appeared first on MedCity News .
Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
The FDA has approved the sunscreen chemical bemotrizinol, a UV light filter that has been available in Europe, Asia, and Australia for more than 20 years. Health advocates and skin care industry groups alike are hopeful it can restore faith in sunscreen.
Statement from the American Diabetes Association Regarding 2026 Scientific Sessions mcarmody Wed, 06/10/2026 - 16:55 Official Statement Statement from the American Diabetes Association Regarding 2026 Scientific Sessions ARLINGTON, Va. June 10, 2026 Today, Charles "Chuck" Henderson, chief executive officer of the American Diabetes Association ® (ADA) issued a statement and apology reflecting on events that occurred during the ADA’s 2026 Scientific Sessions in New Orleans. The ADA is commissioning a thorough independent review of the events that occurred, and we remain committed to…
The FDA has approved changes to the Drugs Facts Label of the over-the-counter (OTC) weight loss drug, alli (orlistat) 60 mg capsules, to warn of risks of acute kidney injury, which is a rare side effect of the medication. The labeling now advises consumers to ask a health care provider before using
Drug repurposing refers to the identification of potential new uses – e.g., a new indication or a new population – of FDA-approved drugs, for which the new uses would be supported by safety and effectiveness data.
SBIA Learn offers a variety of multimedia resources to provide information that is comprehensive, interactive, and easily accessible to small pharmaceutical business and industry.
A Comprehensive Resource for Information on Human Drug Development in Regulation
This virtual training is designed to help staff at academic medical centers meet the federal requirements for registering clinical studies and reporting results on ClinicalTrials.gov.
These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion's untitled letters. FDA may have redacted or edited some of the letters to remove confidential information.
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.