What appears to be a routine item on a routine list of the U.S. Department of Health and Human Services’ (HHS) proposed rulemakings for the next fiscal year is being seen as anything but routine, given HHS Secretary Robert Kennedy’s stance on vaccines and several commonly used drugs.
Urogen Pharma Ltd. has obtained IND approval from the FDA for UGN-501, a next-generation investigational oncolytic virus. A phase I study evaluating intravesical administration of UGN-501 in patients with non-muscle invasive bladder cancer (NMIBC) is expected to begin in the fourth quarter.
Of all the U.S. SEC’s recent proposed rules to make going, and staying, public more attractive, perhaps the most beneficial for biopharma and med-tech startups is the amendment that would give public companies the flexibility to file semi-annual rather than quarterly reports, Ben Bradford, head of external affairs at Massbio, told BioWorld.
LTZ Therapeutics Inc.’s LTZ-232 has gained IND clearance from the FDA, enabling initiation of a phase I study in patients with advanced metastatic colorectal cancer and other solid tumors.
The House Select Committee on China launched an investigation into clinical trials involving U.S. companies that are conducted at Chinese military hospitals and in Xinjiang, China.
Despite the Biosecure Act’s five-year wind-down period that isn’t expected to start until mid-2028, Wuxi Apptec is already feeling the repercussions of being added last month to the U.S. Department of War’s Section 1260H list.
After years of hearings, finger-pointing and litigation, the U.S. Congress finally seems to be getting serious about fixing the 340B prescription drug discount program, which today is the second largest federal drug program.
Opus Genetics Inc. has secured U.S. FDA alignment on an eight-patient phase III trial of its lead gene therapy, OPGx-LCA5, for an ultra-rare form of inherited childhood blindness.
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