Martin Makary

shards of a disc in the air
Biotech

Disc's rare disease drug hit by FDA rejection

Disc’s bitopertin had hit the primary endpoint in what the FDA agreed was an adequate and well-controlled trial.
wheel

Biohaven CEO calls recent FDA decisions 'a systemic problem'

Feb 13, 2026 4:14pm
FDA

FDA names Tracy Beth Høeg as acting head of drug center

Dec 4, 2025 4:03am
Makary

2 lawmakers push for answers as questions swirl over FDA program

Nov 25, 2025 10:30am
Richard Pazdur
Favicon Fierce Pharma

FDA names oncology vet Pazdur as new CDER director

Nov 11, 2025 5:18pm
clock delay wait time alarm

Regenxbio's Hunter gene therapy latest to face FDA delay

Aug 19, 2025 10:30am