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As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023, to keep you updated on laws and regulations that could impact your business. Read More
In this edition of Quick Notes, Vanda gets a new indication for its antipsychotic drug, Daiichi Sankyo and AstraZeneca get a new indication for their oncology drug, multiple myeloma patients can look to earlier use of drugs from Johnson & Johnson and Bristol Myers Squibb, and HHS funds support a new antibiotic approved for three serious infections. Read More
The FDA’s Office of Pharmaceutical Quality (OPQ) finished out 2023 by progressing in all four of its strategic priorities: collaboration, communication, engagement, and innovation, according to its 2023 annual report. Read More
U.S. drugs in shortage have reached “record highs” and policymakers must address gaps in pharmaceutical supply chains to better prepare for future, unanticipated shocks, according to researchers from University of Pittsburgh School of Medicine. Read More
Over the past week, the FDA published two final guidances on electronic submissions. Draft guidance was issued on data integrity for in vivo BA/BE studies. The agency is also seeking nominations for members on two advisory committees. Read More
Following through on a 2023 pledge from its CEO, Amylyx is voluntarily pulling its controversial amyotrophic lateral sclerosis drug Relyvrio/Albrioza (AMX0035; ursodoxicoltaurine) after the drug failed its confirmatory phase 3 study. Read More
Seeking to get back on track for FDA approval of its first-of-a-kind epinephrine nasal spray, ARS Pharmaceuticals says it has provided the agency with responses to all its additional requests in the Complete Response Letter (CRL) the agency send ARS last September. Read More
President Biden continued to push for extending the prescription drug cost-cutting provisions of the Inflation Reduction Act (IRA) beyond Medicare recipients in a speech broadcast on YouTube on Wednesday. Read More
Two pharmaceutical giants — AstraZeneca and Eli Lilly — endured 483 knocks recently: AZ for releasing an out-of-spec bilayer tablet and Lilly for lapses in aseptic technique. Read More