After several delays, the interleukin-15 superagonist Anktiva (nogapendekin alfa inbakicept) from Immunitybio Inc. has been approved by the U.S. FDA for treating bladder cancer, specifically Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors.

Lumicell Inc. sees a brighter future now that it has secured U.S. FDA approval for both its new drug application for Lumisight (pegulicianine) optical imaging agent and premarket approval for the Lumicell direct visualization system.  

Genfleet Therapeutics Inc. has entered the KRAS G12C inhibitor race in the U.S. as it gears up to begin phase III trials of GFH-925 (IBI-351) in patients with refractory metastatic colorectal cancer (CRC) following FDA clearance. GFH-925 was the first KRAS G12C inhibitor to receive breakthrough therapy designation from China's National Medical Products Administration for previously treated advanced CRC.

The U.S. FDA has cleared Centessa Pharmaceuticals plc’s IND to initiate a phase I first-in-human, clinical trial of ORX-750 for the treatment of narcolepsy.

In March, the U.S. FDA approved 30 new drugs, marking the highest monthly count in BioWorld’s records. The previous highest month of June 2020, with 29 FDA approvals, is followed by November 2017’s 27 approvals. In 2023, the FDA greenlit an average of about 16 drugs per month, 12.5 in 2022, and 17 in both 2021 and 2020. The surge in March marks a 173% increase from the 11 drugs approved in February.

Reliance may be the regulatory buzzword of the moment, but mutual recognition agreements between regulators are much more near and dear to the hearts of device makers. Richard Phillips, director of strategy for Association of British Health Tech Industries Ltd., told an audience of device makers that the U.K. is considering recognition of devices approved and cleared by the FDA, although Phillips said such recognition for 510(k) devices might be less than a simple exercise.

Companies that buy other companies know perfectly well that they may acquire a few headaches in the process, but recent enforcement trends are making the acquiring companies more careful about acquisitions. Regulatory attorney Jennifer Bragg told an audience at this year’s meeting of the Medical Device Manufacturers Association (MDMA) that the smarter companies are doing their due diligence before approaching the target company, an exercise that could ultimately dissuade the would-be acquirer of the wisdom of the transaction.

Lumicell Inc. sees a brighter future now that it has secured U.S. FDA approval for both its new drug application for Lumisight (pegulicianine) optical imaging agent and premarket approval for the Lumicell direct visualization system . The company markets the two together as the Lumisystem to detect and resect residual breast cancer. Newton, Mass.-based Lumicell expects the Lumisystem will be available in the fourth quarter of 2024, Lumicell President and Chief Operating Officer Howard Hechler told BioWorld.

The U.K. government said it is taking active steps to ensure that the country’s health and social care system can reliably access safe, effective and innovative technologies. One year following its inaugural medical technology strategy, the government reported changes underway which have already transformed the med-tech sector and consequently patients’ lives.