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The FDA has issued two new guidances on the development of oncology drugs and biologics, posting a final guidance on optimizing cancer drug doses and a draft guidance on developing drugs specifically for Bacillus Calmette-Guérin-unresponsive nonmuscle invasive bladder cancer. Read More
A study of trends in prescriptions dispensed at retail pharmacies for semaglutide showed a 442 percent increase in fills between January 2021 and December 2023 — increasing from 659,000 to 2,270,564 during that time period, according to a recent study. Read More
During the second session of the 118th Congress, FDAnews will track important pending legislation, that has been acted on by Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More
Eli Lilly announced positive results from a phase 3 clinical trial evaluating the safety and efficacy of tirzepatide injection in adults with heart failure with preserved ejection fraction and obesity. Read More
The FDA has provided a case study of how CDER used machine learning to identify a suitable patient population for a COVID-19 treatment that was approved under the emergency use authorization (EUA). Read More
The CDER Office of Pharmaceutical Quality (OPQ) Experiential Learning Site Visit Program (ELSVP) is inviting pharmaceutical companies interested in participating to submit a site visit proposal. Read More
This week, the FDA published final guidance on optimizing the dosage of drugs and biological products for oncologic diseases and draft guidance for developing drug and biological products for bladder cancer. The agency also issued notice of a public workshop on pediatric patient diversity in therapeutics development, a request for comments on information collection associated with a proposed study titled “Healthcare Provider Survey of Topics Related to Prescription Drug Promotion and an OPQ request for proposals for staff site visits. Read More
CDER’s Office of Surveillance and Epidemiology (OSE) made significantly more use of AI and machine learning tools in 2023 to reduce the demands of manual reviews, according to OSE’s latest annual report. Read More
The FDA has announced the availability of the International Council of Harmonisation (ICH) final guidance and questions and answers on drug interaction studies and ICH has issued a final guideline on bioequivalence (BE) studies. Read More
This edition of Quick Notes features announcements of a Recursion and Exscientia merger, Boehringer Ingelheim acquisition of Nerio Therapeutics, BioNTech’s decision to discontinue working with Genmab on acasunlimab, the sale of Mallinckrodt’s Therakos business, expansion of Daiichi Sankyo’s and Merck’s collaboration agreement, and Sangamo’s development deal with Genentech. Read More
Mirati Therapeutics has been issued an untitled letter by the FDA for making misleading online claims about the efficacy of its non-small cell lung cancer (NSCLC) drug Krazati (adagrasib), violations considered especially egregious by the agency due to the condition’s serious and devastating nature. Read More
The FDA has determined that the phase 3 SIERRA trial conducted by Actinium Pharmaceuticals is not adequate to support a BLA filing for Iomab-B to treat patients with active relapsed or refractory acute myeloid leukemia, the company recently announced. Read More