Daiichi Sankyo Co. Ltd. and Astrazeneca plc have submitted a new BLA to the U.S. FDA for accelerated approval for datopotamab deruxtecan for treating locally advanced or metastatic epidermal growth factor receptor-mutated non-small-cell lung cancer patients who have received prior systemic therapies.
Johnson & Johnson received U.S. FDA investigational device exemption to begin the pivotal clinical trial for the Ottava robotic surgical system. If the trial goes well, Ottava could pose a significant challenge to decades-long dominance of the robotic surgical market by Intuitive Surgical Inc.’s Da Vinci system.
Device makers are not necessarily fond of the need to acquire Medicare coverage by picking off one Medicare administrative contractor at a time, but Cleerly Labs Inc. worked this path with gusto.
CSPC Pharmaceutical Group Ltd.’s SYS-6026 has obtained clearance from China’s National Medical Products Administration (NMPA) to enter clinical trials for the treatment of high-grade squamous intraepithelial lesions associated with human papillomavirus (HPV) type 16 or 18.
Antelope Surgical Solutions Inc. has received commercial IND approval from the FDA for its novel prostate cancer technology, AS-1986NS. AS1986NS, a fluorescent and lutetium-175 bearing drug, will be evaluated in trials with the aim of addressing prostate cancer identification and surgical margin delineation.
The FDA has lifted a clinical hold on Carsgen Therapeutics Holdings Ltd.’s. CAR T products after issuing the company a warning letter following a December 2023 FDA inspection that found the company violated good manufacturing practices at its Research Triangle Park facility in Durham, N.C.
The U.S. FDA’s Nov. 1 warning letter to Owens & Minor Inc. criticized the company for a lack of documentation that two components of convenience kits had been validated for sterilization with ethylene oxide.
RSS
