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The FDA has revised the Manual of Policies and Procedures (MAPP) for ANDA assessment practices with changes intended to decrease the number of review cycles needed for approval. Read More
In a move to strengthen its KRAS-targeting oncology portfolio, Bristol Myers Squibb is buying Mirati, the company that developed and launched Krazati (adagrasib), a best-in-class molecule that, when combined with a PD-1 inhibitor, targets non-small cell lung cancers harboring the common mutation. Read More
Alnylam Pharmaceuticals today announced that the FDA has issued a complete response letter (CRL) on its supplemental New Drug Application (sNDA) for Onpattro (patisiran) for the treatment of cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis and will no longer pursue the expanded indication. Read More
The FDA’s plan to modernize its IT infrastructure features several improvements that will benefit clinical trials and sponsors, including upgrades to data-sharing and electronic submissions, support for responsible use of AI/machine learning (ML) and increased collaboration between the agency and industry. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
Cancer centers in the U.S. are still grappling with shortages of critical drugs, according to a new survey by the National Comprehensive Cancer Network. Read More
This year, those making combination products find themselves in a swirl of potentially confusing regulations and standards regarding risk management. Read More
Seeking to address the growing problem of how misinformation undermines confidence in both science and the FDA, the Regan-Udall Foundation has released a report focusing on how the FDA can deliver clear messaging to deliver improved understanding of the FDA and the products it regulates. Read More
Amgen’s open-label confirmatory study of its lung cancer drug Lumakras (sotorasib) had too many data integrity problems to effectively show that the drug is an improvement over the standard-of-care chemotherapy docetaxel, according to the Oncologic Drugs Advisory Committee (ODAC), which met Thursday. Read More