FDA approves first pediatric heart valve built to be expanded as a child grows
Edwards Lifesciences' Autus Size-Adjustable Valve is also the first valve approved in the U.S. with polymeric leaflets instead of animal tissue.
The Priority Review: life sciences news
Latest
-
FDA approves Emcitate, the first treatment for MCT8 deficiency
Egetis Therapeutics' tiratricol treats the excess blood thyroid hormone of Allan-Herndon-Dudley syndrome. The company also received a rare pediatric disease priority review voucher.
-
FDA rewrites drug safety rules to say “nonclinical,” not “animal,” testing
A direct final rule takes effect February 4, 2027, unless the agency receives significant adverse comments by December 7, 2026.
-
FDA approves Fayuvi, the first gene therapy for Sanfilippo syndrome type A
Ultragenyx's one-time AAV9 infusion received standard full approval for children with MPS IIIA, and the company received a priority review voucher.
The stream
-
Boehringer Ingelheim registers study of survodutide in overweight or obesity without diabetes
This study was first posted on ClinicalTrials.gov on October 2, 2026. The Phase IIIb, open-label study plans to enroll 350 participants, with a planned start date of November 7, 2026 and a primary completion date of June 25, 2028.
-
Jiankuan registers Phase 3 trial of proximod in rheumatoid arthritis
Jiankuan (Suzhou) Biotechnology Company Limited registered a Phase 3 trial of proximod for moderate-to-severe active rheumatoid arthritis. The study plans to enroll 590 participants and is expected to start on October 15, 2026.
-
Regeneron registers trial of ALN-CIDEB in Metabolic Dysfunction-Associated Steatotic Liver Disease
This study was first posted on ClinicalTrials.gov on October 2, 2026. The trial plans to enroll 1500 participants and plans to start on November 6, 2026, with primary completion on March 3, 2029.
-
PT Bio Farma registers Phase 3 trial of in-house recombinant Hepatitis B vaccine at birth dose
This study was first posted on ClinicalTrials.gov on October 2, 2026. The trial plans to enroll 270 participants and has a planned start date of October 2026 with a planned primary completion date of February 2027.
-
GlaxoSmithKline registers phase 3 trial of mRNA seasonal influenza vaccine
This study was first posted on ClinicalTrials.gov on October 1, 2026. The trial plans to enroll 3000 participants and aims to evaluate the immunogenicity, reactogenicity and safety of an mRNA-based seasonal influenza vaccine in adults 18-64 years of age.
-
Amgen registers Phase 3 study of inebilizumab in primary membranous nephropathy
This study was first posted on ClinicalTrials.gov on October 1, 2026. The study plans to enroll 159 participants and aims to evaluate the efficacy of inebilizumab on PMN disease activity as measured by complete remission.
-
Novartis registers Phase IIIb trial of zigakibart + atrasentan in primary IgA nephropathy
This study was first posted on ClinicalTrials.gov on September 30, 2026. The trial plans to enroll 340 participants and plans to start December 1, 2026.
-
Results posted for ABC008 study in inclusion body myositis
Results for this study were first posted on ClinicalTrials.gov on October 1, 2026. The study enrolled 272 participants and completed primary data collection on November 6, 2025.
-
Results posted for dexmedetomidine study in dementia agitation
Results for this study were first posted on ClinicalTrials.gov on October 1, 2026. The study, a Phase 3, randomized, double-blind, placebo-controlled trial, enrolled 13 participants and was terminated.
-
Results posted for SM04554 topical solution study in male androgenetic alopecia
Results for this study were first posted on ClinicalTrials.gov on October 1, 2026. The study enrolled 675 participants and completed primary data collection on December 31, 2020.