fda

Wockhardt's intravenous cefepime-zidebactam combination won U.S. FDA approval for complicated urinary tract infections after a phase 3 trial showed superiority over meropenem.

An antisense drug stabilized walking speed in a 54-patient pivotal trial; the FDA accepted Ionis's NDA for Priority Review with a target action date of September 22, 2026.

An FDA decision on Viridian's IGF-1R antibody veligrotug is due June 30, 2026, after Phase 3 trials hit their endpoints in both active and chronic thyroid eye disease.

Vera Therapeutics' dual BAFF/APRIL inhibitor reduced proteinuria 45.7% at week 36 in the NEJM-published ORIGIN 3 trial, with an FDA accelerated-approval decision due July 7.

Agios filed for accelerated approval of mitapivat, an oral pyruvate kinase activator, on the strength of a Phase 3 trial that met its hemoglobin endpoint but missed on pain crises.

The FDA's June 2 draft guidance lets genome-editing sponsors leverage prior CMC, nonclinical, and clinical knowledge across products, with a 90-day comment window.

The FDA has approved Shionogi's ensitrelvir (Xocova) for post-exposure prophylaxis of COVID-19, the first oral antiviral cleared for that indication in the US.

IGNYTE trial data show 83.5% of responders alive at three years; Replimune plans third BLA resubmission after two FDA rejections.

AbbVie's pivekimab sunirine-pvzy wins FDA approval for BPDCN on May 27, with a 69.7% complete remission rate in newly diagnosed patients and the first-ever outpatient initiation for this ultra-rare malignancy.

The FDA on May 13 cleared Taiho Oncology's Inqovi combined with venetoclax as the first fully oral treatment for older or unfit AML patients, replacing injection-based clinic visits.

The FDA granted accelerated approval to Hepcludex (bulevirtide-gmod) on May 22, 2026, making it the first treatment cleared for chronic hepatitis delta virus infection in the United States.

J&J's table-integrated OTTAVA robot completed all 30 gastric bypass procedures without conversion and met safety endpoints, advancing its FDA De Novo application.