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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
After getting a Complete Response Letter (CRL) from the FDA last spring due to manufacturing deficiencies, UCB Pharma says the agency has accepted its biologics license application (BLA) resubmission for bimekizumab for the treatment of adults with moderate-to-severe plaque psoriasis. Read More