The FDA has accepted Pierre Fabre's resubmitted application for tabelecleucel, setting a March 31, 2027 decision date. The review follows two rejection letters, including a January 2026 dispute over whether the ALLELE study adequately establishes effectiveness.
Cyted Health's DETECT-ME study reported 90% sensitivity and 86% specificity for Barrett's esophagus across 324 participants at 18 US sites. The capsule sponge test also identified all cases of dysplasia and esophageal adenocarcinoma in the reported analysis, although subgroup sizes and broader screening performance require careful interpretation.
Estrella has added Intermountain Health LDS Hospital as the fifth site in its Phase 1/2 STARLIGHT-1 study of EB103. Earlier testing found complete responses in five evaluable patients at the higher dose, but the small uncontrolled dataset and the company's financing position remain important development considerations.
The FDA has expanded ANKTIVA plus BCG to adults with BCG-unresponsive high-grade papillary-only non-muscle-invasive bladder cancer. The decision relies on existing clinical evidence and biological similarities with carcinoma in situ, rather than a new pivotal efficacy result specifically demonstrating treatment benefit in papillary-only patients.
Takeda has begun selling ORZEYFUL in Japan and China, introducing the first approved orexin receptor 2 agonist for narcolepsy type 1. Two Phase 3 studies involving 273 patients demonstrated substantial improvements in wakefulness and cataplexy, while the planned US launch remains dependent on controlled-substance scheduling.
The FDA has granted Breakthrough Therapy designation to Legacy Healthcare's investigational topical treatment CINAINU for moderate-to-severe alopecia areata from age two. A pediatric trial showed statistically significant hair-regrowth benefits, although the primary efficacy analysis included only 62 of 107 randomized patients.
Abram Scientific has received a DARPA contract worth up to $8.3 million to advance CoagCare, a portable blood coagulation testing platform designed to provide results in under 10 minutes. The award supports military and civilian development, but regulatory clearance and clinical performance validation remain outstanding.
Providence Medical Technology has announced FDA clearance for CORUS PCSS 3D-T, a porous titanium posterior cervical fusion implant. Its established platform has randomized clinical evidence, but the new implant's incremental clinical benefit remains to be demonstrated.
TuHURA has secured a US patent covering TBS-2025 and related VISTA-targeting antibody designs through February 2042. The intellectual property expansion follows FDA clearance of an early-stage AML study, but clinical efficacy and commercialization remain unproven.
New Phase 3 AFFIRM data show 35.8% endoscopic remission and 36.6% ulcer-free endoscopy with subcutaneous Skyrizi at Week 24. The findings support regulatory applications for an alternative to intravenous induction, although differences in treatment allocation after Week 12 require careful interpretation.