Blackfinbio Ltd. has obtained IND clearance from the FDA for its novel AAV gene therapy, BFB-101, for hereditary spastic paraplegia type 47 (SPG47), which is caused by changes in the AP4B1 gene. A phase I/II trial will be conducted in the U.S. at Boston Children’s Hospital.

The intriguing VEGFxPD-1 bispecific antibody space gained oomph with phase III results disclosed April 23 by Akeso Pharmaceuticals Inc. related to Harmoni-6, testing ivonescimab in combination with platinum-based chemotherapy compared with Tevimbra (tislelizumab, Beigene Ltd.), a PD-1 inhibitor also paired with platinum-based chemo in patients with locally advanced or metastatic squamous non-small-cell lung cancer irrespective of PD-L1 expression. Those data were followed by a green light from the U.S. FDA April 24 for marketing the PD-1 monoclonal antibody penpulimab in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.

Regulatory reliance is all the rage of late, but some nations employ a four-tier risk classification scheme while others use a three-tier scheme.

The U.S. FDA has granted de novo clearance for Epiminder Pty. Ltd.’s Minder implantable device for continuously monitoring brain activity in patients with epilepsy.

The U.S. FDA’s authority to require cybersecurity measures in premarket submissions is a radical change for industry, but firms must document that they have erected solid cybersecurity measures.

In all practicality, U.S. FDA Commissioner Marty Makary’s recently announced policy directive removing industry representatives from the agency’s advisory committees may have little effect on the makeup of the drugs and devices committees, which typically include them as nonvoting members.

The use of Renalytix plc’s Kidneyintelx biomarker-based prognostic test led to increased and targeted use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in patients at risk of diabetic kidney disease, compared to untested patients, according to data from a study.

Staffing cuts at the FDA’s device center led to speculation that the current user fee program may be fatally damaged, but Mark Leahey, president and CEO of the Medical Device Manufacturers Association, said in a meeting in Columbus, Ohio that there are too many resources for FDA at stake for the user fee program to be ended.