FDA moves to allow leucovorin as treatment for autism symptoms
Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at…
Covid drugmakers must ‘justify’ success after new vaccine limits
U.S. President Donald Trump in the Cabinet Room of the White House on Aug. 26, 2025 in Washington,…
The FDA overhauled its COVID vaccine guidance. What it means for you
New federal guidance surrounding COVID vaccine authorization could make it more difficult for many people to be inoculated…
FDA ends emergency use authorization for Covid vaccines
WASHINGTON — The Food and Drug Administration on Wednesday approved updated Covid boosters, but removed emergency use authorizations…
Shrimp, salad kits and more: See list of FDA food recalls in 2025 so far
The Food and Drug Administration (FDA) recently recalled frozen shrimp imported from an Indonesian firm over fears of…
Phase 3 Trial Confirms Sarilumab Improves Polymyalgia Rheumatica Outcomes
Vibeke Strand, MD Credit: PRIME Education New phase 3 data supported the effectiveness of sarilumab 200 mg every…
Vinay Prasad returns to the FDA, weeks after his ouster
WASHINGTON — Vinay Prasad is returning to the Food and Drug Administration to resume his role overseeing vaccine,…
Vinay Prasad departs FDA | STAT
Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall…
As Sarepta, FDA tangle over Duchenne therapy, families are caught in the middle
Jennifer Hill Blair recognized the Cincinnati number on her buzzing phone and slipped out of the school meeting,…
Sarepta Therapeutics’ Elevidys faces ‘arduous’ path back to market
Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall…
FDA rejects Replimune skin cancer therapy
Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall…
FDA rejects Capricor’s Duchenne cell therapy
Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall…