Approvals
The FDA approved bluebird bio’s lentiviral vector (LVV) eli-cel Friday as the first therapy to slow the progression of neurologic dysfunction in juvenile boys with early, active CALD.
With 33 approvals from the FDA, Merck’s checkpoint inhibitor Keytruda has become a powerhouse oncology drug and is likely to continue to rack up more regulatory wins.
The U.S. FDA approved Mallinckrodt’s Terlivaz in adults with hepatorenal syndrome and is the only FDA-approved drug for that indication.
BMS announced that the FDA approved Sotyktu for adults with moderate-to-severe plaque psoriasis, marking this indication’s first oral treatment innovation in nearly a decade.
Although it was a short week due to the Labor Day holiday, the FDA maintained a steady pace of business.
The FDA approved AstraZeneca’s Imfinzi plus with gemcitabine-cisplatin chemotherapy as the first immunotherapy for adult patients with locally advanced or metastatic biliary tract cancer.
The U.S. Food and Drug Administration had a busy week leading up to the Labor Day holiday. Here’s a look at the agency’s recent activities.
Boehringer announced that the FDA approved Spevigo for generalized pustular psoriasis flares in adults, the first drug approved for this indication.
On Wednesday, the FDA authorized new Omicron-specific booster shots for Pfizer-BioNTech and Moderna’s COVID-19 vaccines despite a lack of human data.
Sanofi announced FDA approval of Xenpozyme for adult and pediatric patients with the rare genetic disease acid sphingomyelinase deficiency, often referred to as Niemann-Pick disease.
PRESS RELEASES