It appears the end has come for Jacobus Pharmaceutical’s Ruzurgi, a potassium channel blocker that had received an Orphan Drug designation from the FDA for treatment of Lambert-Eaton myasthenic syndrome…
FDA investigators observed faulty HEPA filters close to products being manufactured and other quality lapses at Catalent’s Brussels drug facility during an October 2021 inspection. Source: Drug Industry Daily
The FDA’s Center for Drug Evaluation and Research (CDER) plans to publish almost 100 new and revised draft guidances this year, according to the center’s 2022 guidance agenda — about…
The FDA outlined clinical pharmacology considerations for developers of antibody-drug conjugates (ADCs) in a draft guidance released yesterday. Source: Drug Industry Daily
The FDA’s Center for Drug Evaluation and Research (CDER) plans to publish almost 100 new and revised draft guidances this year, according to the center’s 2022 guidance agenda — about…
A group of drug and device companies is asking the U.S. Court of Appeals for the D.C. Circuit to toss out its recent decision to revive a lawsuit in which…
As his confirmation to the top spot at the FDA hangs precariously in the balance, Robert Califf seems to be making a lot of concessions to lawmakers even as support…
Two research groups at odds over who invented the game-changing CRISPR gene-editing technology appeared before the U.S. Patent and Trademark Office (USPTO) on Friday to argue their cases. Source: Drug…
FDA’s top cancer specialist is already waving a red flag at sintilimab, saying the Eli Lilly-licensed Chinese oncology drug — scheduled for review by an FDA advisory committee this week…
The FDA needs to hire more investigators to conduct overseas inspections to reverse a decline in foreign site visits, the Government Accountability Office (GAO) said in a report released yesterday.…