Drug companies with a candidate nonopioid analgesic should consider applying for expedited review through FDA’s special approval pathways, according to new draft guidance released yesterday. Source: Drug Industry Daily

The FDA outlined clinical pharmacology considerations for developers of antibody-drug conjugates (ADCs) in a draft guidance released yesterday.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…

Pfizer’s COVID-19 vaccine racked up $36.8 billion in total sales in 2021, making it the single-highest annual sales total of any pharmaceutical product ever. Source: Drug Industry Daily

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…

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…