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This month, our review of recent clinical trial results features Rinvoq’s sustained remission in almost half of Crohn’s disease patients, Novo Nordisk’s semaglutide showing significant patient weight loss, and improved insulin and fasting glucose levels in a phase 2B study of Akero Therapeutics’ human fusion protein efruxifermin.Read More
CDER formal dispute resolution (FDR) procedures on how to appeal a final order for OTC monograph drugs are outlined in a draft guidance the FDA released on Thursday. Read More
Heavy reliance on foreign manufacturing for essential medicines is at the root of FDA concerns over supply chain and drug shortages, according to a report from the FDA Office of Pharmaceutical Quality (OPQ) that shows 82 percent of API and 57 percent of finished dosage form manufacturing sites are outside the U.S. Read More
Following multiple years of development, the streamlined version of the ClinicalTrials.gov website officially launched Wednesday, providing users with a revised, simplified layout intended to enhance efficiency and usability. Read More
The International Council for Harmonisation’s (ICH) governing group announced earlier this month it will begin work on new guidelines in three areas: patient preference, nonclinical safety evaluation for oligonucleotide-based therapies and bioequivalence for modified-release products. Read More
Upcoming events in the coming weeks include three FDA advisory committee meetings as well as webinars on the FDA’s sterilization pilot and design control. Read More
To better understand the performance of the in vitro diagnostic tests used to identify the right treatment for cancer patients, the FDA has begun a pilot project for CDER-regulated oncology drugs and the corresponding clinical assays. Read More
Bristol Myers Squibb (BMS) filed suit against HHS and CMS over the Inflation Reduction Act (IRA) claiming that the drug price negotiation program violates the Constitution by “forcing pharmaceutical companies to turn over their most successful and innovative products at a huge discount.” Read More
The FDA’s list of regulations it plans to propose or finalize in the next 12 months, released Tuesday, includes more than 30 proposed and final rules related to drug, device and biologics products. Target release dates vary by rule. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More