August 28, 2026
Drug Recalls - Availability
Vitruvias Therapeutics – Recall of thyroid tablets, USP 30 mg
August 21, 2026 - Vitruvias Therapeutics announced a voluntary, consumer-level nationwide recall of one lot of Thyroid Tablets, USP 30 mg because testing confirmed the potential for the product to be superpotent.
Drug Approvals
Genglycos™ (pariglasgene brecaparvovec-opnr) – New orphan drug approval
August 19, 2026 - The FDA announced the approval of Ultragenyx’s Genglycos (pariglasgene brecaparvovec-opnr), to reduce daily cornstarch intake as an adjunct to nutritional management in adult and pediatric patients 8 years of age and older with glycogen storage disease type Ia (GSDIa).
Drug Approvals
Pasatru™ (garetosmab-grts) – New orphan drug approval
August 19, 2026 - Regeneron announced the FDA approval of Pasatru (garetosmab-grts), to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP).
Clinical Updates
Imaavy® (nipocalimab-aahu) – New indication
August 24, 2026 - Johnson & Johnson announced the FDA approval of Imaavy (nipocalimab-aahu), for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids.
Clinical Updates
Ziihera® (zanidatamab-hrii) – New indication
August 25, 2026 - The FDA announced the approval of Jazz Pharmaceuticals’ Ziihera (zanidatamab-hrii).