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Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace,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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The FDA’s decision is based on positive results from two induction and one maintenance clinical study of AbbVie’s Skyrizi for Crohn’s disease.
VBI Vaccines and Hepion Pharmaceuticals have received Orphan Drug Designations from the U.S. Food and Drug Administration for their experimental cancer drugs.
Friday morning, the FDA granted Emergency Use Authorization to both Moderna’s and Pfizer-BioNTech’s COVID-19 vaccines for use in children ages 6 months to 4 years old.
The FDA approved Rhythm Pharmaceutical’s Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome.
A recent study found that over a span of ten years, the FDA approved cancer drugs approximately eight months earlier than the same drugs were greenlit by the European Commission (EC).
The FDA has approved Alnylam Pharmaceuticals’ Amvuttra (vutrisiran) for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy in adults.
Eli Lilly’s Olumiant (baricitinib) received approval from the FDA for the treatment of severe alopecia areata, making it the first systemic treatment for adults living with the disease.
ION582 is uniquely formulated using RNA technology to provide relief to patients with Angelman syndrome, a rare disorder for which limited treatment options are available.
The House of Representatives voted on a bill that would give the U.S. Food and Drug Administration more power to ensure biopharma companies run large follow-up trials to confirm accelerated approvals.
The approval expands the rapidly growing number of indications for Dupixent, which is the first and only biologic medication with the FDA’s nod to treat atopic dermatitis from infancy to adulthood.