#fda

Conceptual illustration of an IV nutrition bag and neonatal care

Regulatory

FDA Moves to Keep IV ‘Starter Nutrition’ Flowing to Fragile Newborns

With two suppliers shutting down, the FDA is deploying regulatory tools to prevent a shortage of the intravenous nutrition that premature and critically ill babies depend on.

12 hr ago · 1 min read

Conceptual illustration of a transdermal patch and a supply gap

Health

A US Shortage of Estradiol Patches Is Squeezing Menopause and Gender-Affirming Care

Surging demand for hormone therapy has outstripped supply of the transdermal patches, and the FDA is pressing manufacturers to ramp up production.

1 day ago · 1 min read

Conceptual illustration of gene therapy delivered to the brain

Regulatory

UniQure Files for FDA Approval of a Gene Therapy for Huntington’s Disease

After a bruising regulatory saga, the company submitted AMT-130 — a one-time, brain-delivered gene therapy that slowed disease progression over three years — for accelerated approval.

3 days ago · 1 min read

FDA Moves to Keep IV &lsquo;Starter Nutrition&rsquo; Flowing to Fragile Newborns

A US Shortage of Estradiol Patches Is Squeezing Menopause and Gender-Affirming Care

UniQure Files for FDA Approval of a Gene Therapy for Huntington&rsquo;s Disease

FDA Moves to Keep IV ‘Starter Nutrition’ Flowing to Fragile Newborns

UniQure Files for FDA Approval of a Gene Therapy for Huntington’s Disease