The FDA recently cleared the TruDi Shaver Blade, an electromagnetically navigated blade for the incision and removal of soft and hard tissue or bone in ear, nose, throat, and maxillofacial surgery, as well as head and neck and skull-base surgery.

Orna is retaining full ownership of its "crown jewel," in situ CAR programs for cancer. CEO Tom Barnes talked to Scrip about the deal and Orna's business strategy.

Syngene’s COO, Mahesh Bhalgat, tells Scrip the firm is better placed than some peers to serve clients for biologics-based advanced therapies and address the cost element for new modalities like mRNA. He also outlines the research, development and manufacturing services company's capabilities in oligonucleotide-based therapeutics, an area that's seeing growing interest.

Agency policy now allows several others, along with the FDA chief scientist, to authorize emergency use of products, including CBER Director Peter Marks, who signed the EUA for the modified dosing of the monkeypox vaccine.