GT Biopharma Inc. has filed an IND application with the FDA for GTB-5550 TriKE, a B7-H3-targeted natural killer (NK) cell engager for the treatment of B7-H3-expressing solid tumor cancers. Pending approval, the planned phase I basket trial will evaluate GTB-5550 administered subcutaneously in solid tumors.
The EMA had its second busiest year ever in 2025, approving 104 drugs, of which 38 had a new active substance. Sixteen of these are for treating rare diseases, and four are advanced therapy medicinal products.
The U.S. FDA has endorsed ISO 14971 for risk management for medical device manufacturers, but there’s nothing compulsory about industry’s use of this standard. Nonetheless, Sarah Moore, principal program lead at NSF, told BioWorld that adoption of 14971 is still the most seamless way to demonstrate proper risk management practices to FDA field investigators, given that the alternative is almost always more work for both sides during facility inspections.
Years after approving three glucagon-like peptide-1 (GLP-1) receptor agonists to treat obesity, the U.S. FDA is acknowledging that the drugs don’t have the same risk seen with older weight-loss medicines. Citing its post-market evaluation that found no increased risk of suicidal ideation or behavior, the U.S. FDA is requesting that the risk be removed from the warnings and precautions section of labeling for the GLP-1 obesity drugs – Eli Lilly and Co.’s Zepbound (tirzepatide) and Novo Nordisk A/S’ Saxenda (liraglutide) and Wegovy (semaglutide).
The U.S. FDA’s Jan. 14 webinar for the new Quality Management System Regulation included some fairly predictable content, but one member of the FDA staff mentioned that the agency now expects corporate management to demonstrate the correct “attitude” with regard to product quality, suggesting that agency staff will be more keen to crack down on firms that dispute the agency’s perspectives on quality management.
Boston Scientific Corp.'s Farapoint, its latest pulsed field ablation catheter, received U.S. FDA approval for use as an adjunctive device when treating persistent atrial fibrillation that requires cavotricuspid isthmus ablation, CEO Mike Mahoney reported at the J.P. Morgan Healthcare Conference in San Francisco. The newest member of the popular Farapulse family of PFA catheters provides a focal point option for creation of straight line or focal lesions, complementing the larger, single-shot Farawave catheter that has dominated the PFA market since its U.S. approval in early 2024.
The FDA’s Center for Devices and Radiological Health has withdrawn its December 2017 final guidance for clinical evaluation of software as a medical device, a development that seems to align with recent relaxation of digital health product regulation, but which might also be seen as the consequence of an ill-advised case of regulatory copy and paste.
Depending on who you ask, AI will take over the world and save it; or ruin it. Certainly, it is changing it. Science magazine dedicated its first editorial of 2026 to AI. Despite its title – “Resisting AI slop“ – editor-in-chief Holden Thorp gave the sort of nuanced review that is typical of him.
Dispatch Biotherapeutics Inc. has obtained IND clearance from the FDA for DISP-10, enabling the initiation of a phase I study in patients with solid tumors. Initial clinical evaluation will begin in gastrointestinal cancers, with plans to expand into multiple additional solid tumor indications following clinical proof of concept.
A second complete response letter issued by the U.S. FDA for Atara Biotherapeutics Inc.’s allogeneic T-cell immunotherapy Ebvallo (tabelecleucel) for Epstein-Barr virus positive post-transplant lymphoproliferative disease is “a complete reversal of position” by the agency, which had previously confirmed the single arm Allele trial was enough to support a BLA under the accelerated approval pathway, the company said.
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