FDA approves new use of synthetic vitamin B9 — but not for autism symptoms

The FDA announced a new approved use for the drug leucovorin, which Trump has touted as a treatment for autism. But the ...

FDA approves generic drug for a rare genetic condition, but not for autism

Dr. Marty Makary, the FDA’s commissioner, said in a statement that the “approval represents a significant milestone for ...
Healio

FDA approves third RSV vaccine for high-risk younger adults

The FDA has approved a third respiratory syncytial virus vaccine for high-risk adults aged younger than 50 years — a ...
Ophthalmology Times

FDA approves Johnson & Johnson's TECNIS PureSee EDOF IOL

FDA approval supports US commercialization of TECNIS PureSee, an EDOF IOL for implantation during cataract surgery, with availability anticipated later in 2026. PureSee is positioned to preserve ...

The best FDA-approved baby formula, per a pediatric expert

Parents and caregivers can attest: feeding a baby is no easy feat, and often comes with a learning curve. In the wake of the ByHeart formula recall and the recent infant botulism outbreak linked to ...
Opinion
BioSpaceOpinion

What the Leucovorin Approval Signals—or Doesn’t—About the FDA’s Rare Disease Stance

Although FDA Commissioner Marty Makary promised “an exciting treatment” for autism, what the agency delivered was a label expansion for leucovorin to treat the ultrarare cerebral folate deficiency.
Pharmaceutical Technology on MSN

FDA approves GSK’s Wellcovorin for cerebral folate deficiency

FDA worked with GSK to update Wellcovorin labelling for safe, effective use in adult and paediatric CFD-FOLR1 patients.

FDA approves Wellcovorin for ultra-rare disease. The Trump admin touted it as a treatment for autism

The Food and Drug Administration (FDA) on Tuesday granted expanded approval to Wellcovorin for the ultra-rare disease cerebral folate deficiency (CFD) in both children and adults, the same ...
Today

FDA Approves New Drug to Treat Menopause Symptoms

The FDA has now approved a new drug, the hormone-free medication Lynkuet, that is used to help treat hot flashes and night sweats brought on by menopause. NBC’s medical contributor Dr. Natalie Azar ...

Vanda Pharmaceuticals Announces FDA Approval of BYSANTI™ (milsaperidone) for the treatment of Bipolar I Disorder and Schizophrenia - A New Chemical Entity Ope…

Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved ...

FDA-approved cancer drug fedratinib reshapes how cell organelles communicate, providing new therapeutic avenues

Cells behave like cities and organelles carry out infrastructural roles: mitochondria are powerhouses, the endoplasmic reticulum serves as a transport hub and lysosomes help with waste disposal.

No Broad Autism Approval for Leucovorin, Despite FDA Commissioner’s Prior Suggestions

The Food and Drug Administration on March 10 changed the approval for a version of the prescription drug leucovorin to include people with a very rare genetic condition. FDA Commissioner Dr. Marty ...