FDA monthly preview: Key November decisions to watch

• by Mouj Hijazi

• October 29, 2026

Anticoagulant recalled over life-threatening risk

Contamination in 22 lots of the injection may cause pulmonary embolism or vascular occlusion; no related adverse events reported.

• by Mouj Hijazi

• October 15, 2026

• 3 min

FDA approves first therapy for symptomatic dermographism

The oral BTK inhibitor produced a complete hive response in 29.3% of treated patients at week 12.

• by Teraya Smith

• October 7, 2026

• 2 min

FDA approves new treatment for FOP

Total new heterotopic ossification volume decreased with treatment and increased with placebo at week 24.

• by Kathryn Wighton

• September 28, 2026

• 2 min