Regulatory
Ascidian Therapeutics, a member of BioSpace’s NextGen Class of 2024, on Monday announced it received IND clearance from the FDA and was granted Fast Track designation for ACDN-01.
The FDA has granted Priority Review for AstraZeneca and Daiichi Sankyo’s supplemental BLA for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumors.
The FDA’s myriad acronyms—and the differences between them—can be perplexing. BioSpace looks at the unique advantages of certain regulatory classifications for drug developers.
While the FDA continues to investigate reported cases of T cell malignancies in patients who received CAR-T therapies, the cause of the secondary cancers remains unclear.
After missing its Jan. 24 PDUFA date, the regulator has extended its review period but has not issued a new decision timeframe or requested additional data, Liquidia announced Thursday.
More than 3,000 people in the U.S. suffered from side effects of Ozempic in 2023, according to exclusive reporting on Wednesday from Reuters citing data from America’s Poison Centers.
The FDA’s Peter Marks and Nicole Verdun in the NEJM Wednesday disclosed that more than 27,000 CAR-T doses have been administered in the U.S. as of the end of 2023, of which there are 22 cases of T-cell cancers.
While the FDA considers a T cell malignancy risk to be applicable to all commercial CAR-T therapies, Gilead Sciences’ Tecartus has a revised warning that potential adverse events “may” occur.
The regulator’s Complete Response Letter flagged issues with the new formulation of tesamorelin’s chemistry, manufacturing and controls and sought more information about its immunogenicity risk.
The company said it’s preparing to file a New Drug Application with the FDA on the strength of late-stage study data for its investigational RNA-targeted donidalorsen in patients with hereditary angioedema.
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