Bristol Myers Squibb and Bluebird Bio re-file their BLA for idecabtagene vicleucel, indicated for treating patients with heavily pre-treated relapsed ...
Catalyst Pharmaceuticals loses against FDA in a lawsuit over the agency's approval of competitor Jacobus Pharmaceuticals Ruzurgi (amifampridine).
Eton Pharmaceuticals files an NDA for zonisamide oral suspension for treating partial seizures in patients with epilepsy.
FDA seeks comment on a proposal to add four bulk drug substances to the bulk list for drug compounders.
FDA grants Takeda Pharmaceutical a breakthrough therapy designation for its investigational drug pevonedistat for treating patients with higher-risk m...
Federal Register notice: FDA makes available a draft guidance entitled Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescripti...
FDA reminds patients, caregivers, and healthcare providers about the risks associated with deep brain stimulation devices when used to treat Parkinson...
FDA says its next Webinar on respirators and other personal protective equipment will be on 8/4.