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The United States Pharmacopeia (USP) and the FDA are working together to promote opportunities for sponsors to develop new generic medications for off-patent drugs that currently lack an approved generic equivalent. Read More
Intensive sessions of behavioral modification — not weight loss drugs — are the best way to treat children and teens who are overweight or obese, according to new treatment recommendations issued by the United States Preventive Services Task Force (USPSTF). Read More
The FDA has finalized two draft documents that provide guidance for sponsors developing and testing oligonucleotides, and drugs to treat diabetic foot infections without bone or joint involvement. Read More
According to the FDA, the selected START participants will be able to obtain frequent advice and regular ad-hoc communication with agency staff. Read More
The FDA’s 11-person Peripheral and Central Nervous System Drugs Advisory Committee unanimously endorsed both the efficacy and safety of Lilly’s antiamyloid antibody donanemab, saying that people with Alzheimer’s disease and their clinicians should be the ones to decide whether the drug’s modest cognitive benefit outweighs its risk of serious adverse events. Read More
The FDA has selected seven rare disease therapies to participate in its Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program to accelerate the development of novel drug products through, in part, enhanced communications with the agency. Read More
The Association for Accessible Medicines (AAM) Biosimilars Council’s recent white paper recommends the FDA streamline its regulation of biosimilar development to allow more affordable biologics products to the market more quickly across the globe. Read More
This month a dextromethorphan-based medicine flunked out for AD agitation, but agents for schizophrenia, mantle cell lymphoma and a clotting disorder did well, with some ready to make the regulatory leap. Read More
The FDA’s draft guidance on platform technology designations for drug development outlines how sponsors can submit a designation request and the benefits of the designation. Read More
Without strong economic incentives, the current antibiotic development pipeline won’t keep pace with burgeoning rates of antibiotic resistance, according to a new study by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Read More
In an analysis that seeks to help frame the discussion at the upcoming Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee, the FDA says that a law enacted in 2017 has increased the number of planned studies to test drugs for pediatric cancers compared to earlier regulatory laws. Read More