FDA
The FDA in a complete response letter to Replimune maintained its original objection to the single-arm trial the biotech used to support the application for RP1.
FEATURED STORIES
The FDA has some big verdicts lined up in the second quarter, including one for a closely watched obesity drug that many anticipate will further intensify competition in weight loss.
Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace, particularly emphasizing the agency’s recommendations around defining NAMs’ regulatory purpose.
The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic representative Jake Auchincloss said last month, as regulatory and biopharma leaders try to decode the criteria for investigational or approved drugs to receive a voucher.
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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.
The long-awaited review of problematic opioid prescribing is taking longer than observers had hoped.