US Food and Drug Administration layoffs appear to be affecting programs that track drug safety. Fired workers from the Division of Drug Information, which conducts safety monitoring, say the DDI team ...

Nearly 70% of cancer drugs granted FDA accelerated approval between 2011 and 2020 required safety updates within 4 years.“Postmarketing safety actions are common,” Maryam Mooghali, MD, MSc, internal ...

In the early 1960s, after studies confirmed that it was linked to congenital disorders in more than 10,000 children, ...

Generic drugs account for more than 90 percent of prescriptions filled in the United States. Recent studies have found concering variability in quality and safety America’s generic drug supply, most ...

Founded by Flagship Pioneering in 2019, Cellarity seeks to embrace biology’s complexity, as diseases are often not driven by a single target, but emerge from a cascade of cellular interactions that ...

A new study published in Therapeutic Innovation & Regulatory Science provides crucial insights into the design and implementation of multi-national observational studies for post-marketing drug safety ...

A drug safety group has delivered a positive analysis for a Sarepta Therapeutics-licensed RNA medicine, with the same study also hitting an enrollment target, triggering a $200 milestone payment due ...

Prescription and over-the-counter (OTC) medications play vital roles in treating health conditions for older adults, helping ease symptoms and supporting overall well-being. To ensure the intended ...

Publication illustrates capabilities of Cellarity’s industry-leading AI and multi-omics-powered platform to clarify hepatotoxic pathways and improve drug safety Cellarity, a clinical-stage ...

A drug’s therapeutic index is a ratio that doctors use when prescribing medications and determining dosage. It shows how much of a drug a person’s blood can contain before it becomes toxic. The ...

The Indian Pharmacopoeia Commission has signed memoranda with the Goa State Pharmacy Council, Quality Council of India, and HLL Infra Tech Services to strengthen drug safety, quality assurance and ...

For older adults, both prescription and over-the-counter (OTC) medications play a vital role in treating health conditions. They help ease symptoms and support overall well-being. To ensure the ...