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Novartis’ 2022 complaint against several generic drugmakers for allegedly infringing on a patent for its blockbuster heart failure drug Entresto (sacubitril/valsartan) was denied on Tuesday, but the judge gave the company a stay in the order to allow it to appeal in federal court. Read More
From a warning that the new pricing scheme doesn’t mean patients are protected from increased costs to another that the Inflation Reduction Act (IRA) pricing scheme will limit patients’ access to medicines now and in the future, big pharma has expressed its displeasure with the public unveiling of prices. Read More
The FDA is inviting comments, for consideration by WHO, concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of eight narcotic drugs. Read More
After a bumpy road to approval, the FDA has approved ARS Pharmaceuticals’ neffy (epinephrine nasal spray) for the emergency treatment of Type I allergic reactions, including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 66 pounds. Read More
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on the development of oncology drugs and biologics, posting a final guidance on optimizing cancer drug doses and a draft guidance on developing drugs specifically for Bacillus Calmette-Guérin-unresponsive nonmuscle invasive bladder cancer.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
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
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
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