Most cancer drugs that gain an Accelerated Approval don’t end up showing any clinical benefit in their confirmatory trials, exposing thousands of patients to ineffective therapeutics that may linger on…
Supernus Pharmaceuticals and IntelGenx have recently received Complete Response Letters (CRL) from the FDA requesting additional quality information on their drug-device combination products. Source: Drug Industry Daily
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…
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…
A genetic risk assessment for opioid addiction approved by the FDA “may make the opioid crisis worse,” according to 31 physicians, researchers and scientists who ripped the agency and the…
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.…
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…
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 Draft guidance was issued on data integrity for in vivo BA/BE studies.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…
While Johnson & Johnson just announced its plans to acquire Shockwave Medical for $13.1 billion, Boston Scientific faces an FTC request for more information on its $3.7 billion acquisition of…
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…