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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 two-thirds of which were previously on CDER’s 2021 agenda. Read More
The FDA outlined clinical pharmacology considerations for developers of antibody-drug conjugates (ADCs) in a draft guidance released yesterday. Read More
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 (LEMS) in children age six to 16, but had yet to be approved. Read More
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. Read More
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 plaintiffs are seeking to hold the companies liable for aiding in the funding of acts of terror in Iraq. Read More
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 — might not be suitable for a U.S. approval based on its single-country pivotal trial data. Read More
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 for his nomination from the medical community and the industry swells. Read More
The FDA has finalized its guidance to help drug sponsors develop population pharmacokinetic (PK) analyses used in drug development to fine-tune dosing regimens. Read More