India, Sept. 29 -- The FDA's October decision calendar looks relatively light, with only a limited number of PDUFA dates scheduled.
As we turn to October, here's a recap of some of the regulatory developments that made headlines in September.
The month saw several notable FDA milestones, including approvals that marked important firsts in the treatment of rare diseases.
Ionis Pharmaceuticals Inc.'s (IONS) Zanvastro received FDA approval on September 3, becoming the first drug approved to treat Alexander disease, a rare neurological disorder.
On September 17, the FDA approved Ultragenyx Pharmaceutical Inc.'s (RARE) gene therapy Fayuvi as the first treatment for pediatric patients with Sanfilippo syndrome type A, a rare, progressive neuro...