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Intercept Pharmaceuticals has resubmitted its new drug application (NDA) for obeticholic acid (OCA) for the treatment of patients with pre-cirrhotic liver fibrosis secondary to nonalcoholic steatohepatitis (NASH). Read More
The FDA hit Smithfield Bioscience with a Form 483 over unexplained batch discrepancies for its blood thinner heparin — a repeat observation from 2019 — following a July 2022 inspection of the company’s Cincinnati, Ohio, facility. Read More
During fiscal 2022, a period where the FDA ramped up its onsite drug inspections after a pandemic-era decline, the agency significantly targeted pharma companies for sterility-related concerns. Read More
The Department of Justice (DOJ) has filed a civil suit against AmerisourceBergen for the company’s alleged role in the opioid epidemic for violating its “critical responsibility in distributing controlled substances to customers across the country.” Read More
With user fee legislation now firmly in place, a new Congress ready to begin legislating in 2023, and an omnibus package signed into law funding the FDA for another year, we talked with Steven Grossman, executive director of the Alliance for a Stronger FDA, about the big issues that face the agency as we head into the new year. Read More
The FDA has granted Ardelyx’s appeal following a Complete Response Letter, allowing the company to resubmit a new drug application (NDA) for its chronic kidney disease (CKD) drug candidate Xphozah (tenapanor). Read More
An inadequate response to a Form 483 about deviations in current good manufacturing practice (cGMP) led to an FDA warning letter for MD Pharmaceutical Supply’s active pharmaceutical ingredients (API) repackaging and relabeling facility in Hanover, Pa. Read More
Trading on an inside-track relationship with FDA regulators, Biogen leveraged the Accelerated Approval pathway to bring to market its controversial antiamyloid antibody, Aduhelm (aducanumab), an 18-month Congressional investigation has found. Read More
Pfizer has posted positive topline phase 3 numbers for its fidanacogene elaparvovec infusion, setting the stage for an escalation in the race with CSL Behring to cure hemophilia B via gene therapy. Read More