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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
Ipsen Biopharmaceuticals has received a Complete Response Letter (CRL) from the FDA for palovarotene, the company’s investigational treatment for the ultra-rare bone disease fibrodysplasia ossificans progressiva (FOP). Read More
NICE is not recommending Enhertu for routine National Health Service use because a clinical trial is ongoing, making the cost-effectiveness estimates very uncertain. Read More
President Biden signed into law a $1.7 trillion omnibus spending package on Dec. 23, appropriating $3.5 billion in discretionary funding for the FDA through Sept. 30, 2023 — an increase of $226 million, or 6.5 percent, from what was enacted for the agency in 2022. Read More