FDA Weighs Looser Peptide Rules
WASHINGTON, D.C., Los Angeles Times, HealthCareDive, BioSpace, RAPS and Medical Dialogues report that the Food and Drug Administration has scheduled a July advisory review that could reopen compounding access for…
U.S. Launches $144 Million Microplastics Health Initiative
WASHINGTON, D.C. — The U.S. Environmental Protection Agency and the Department of Health and Human Services have unveiled a historic joint initiative to regulate and eliminate microplastics from American drinking…
FDA launches adverse event look-up tool
Silver Spring, Maryland — The U.S. Food and Drug Administration says it has launched a unified platform for collecting and analyzing adverse event reports across regulated product categories, with a…
HHS delays preventive care panel again
Basel, Switzerland — Novartis announced positive two-year results from its Phase III APPLAUSE-IgAN study, demonstrating that its oral treatment Fabhalta significantly slowed kidney function decline by nearly 50% in adults…
CDC Pauses Key Infectious Disease Testing
ATLANTA, Ga. — The Centers for Disease Control and Prevention has paused more than two dozen infectious-disease diagnostic tests, including rabies and poxvirus assays, while federal officials conduct what they…
Weekly Extended-Release Buprenorphine Shows Superior Results for Opioid Use Disorder in Pregnancy
CINCINNATI, Ohio — A groundbreaking clinical trial funded by the National Institutes of Health (NIH) HEAL Initiative and conducted through the NIDA Clinical Trials Network has demonstrated that weekly extended-release…
U.S. Measles Outbreaks Threaten Elimination Status
ATLANTA, Georgia — Measles outbreaks across the United States are intensifying as vaccination coverage remains below the level needed to reliably prevent sustained transmission, prompting renewed warnings that the country…
Novartis Drug Fabhalta Slows Kidney Decline by Nearly Half in Phase III Study
Basel, Switzerland — Novartis announced positive two-year results from its Phase III APPLAUSE-IgAN study, demonstrating that its oral treatment Fabhalta significantly slowed kidney function decline by nearly 50% in adults…
FDA lifts age limit for Neffy
SAN DIEGO, Calif. — The U.S. Food and Drug Administration approved a label update for the 1 mg dose of neffy, an epinephrine nasal spray used in allergic emergencies, removing…
FDA Approves Avlayah for Hunter Syndrome
WASHINGTON — U.S. regulators have granted accelerated approval to Avlayah, a new treatment aimed at neurologic symptoms in children with Hunter syndrome, a rare inherited disorder. Our curated coverage draws…