Phase III
Extension data from the Phase II TOPAZ trial showed that apitegromab yielded sustained and continued benefits in non-ambulatory patients with types 2 and 3 spinal muscular atrophy (SMA).
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.
BioSpace spoke with Janssen’s Fiona Elwood about the company’s myasthenia gravis candidate nipocalimab, which is currently recruiting for two Phase III trials.
BMS, TG Therapeutics, Spero and Merck are all preparing for PDUFA dates over the next couple of weeks. Here’s a closer look.
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.
Addex Therapeutics announced it is canceling its Phase IIb/III study evaluating its drug dipraglurant due to patient recruiting, staffing and pandemic-related issues.
Genmab and AbbVie announce positive data in large b-cell lymphoma, Intra-Cellular’s bipolar depression candidate hits the endpoint in Phase III and more.
Bavarian Nordic announced that the upcoming Phase III trial for its COVID-19 booster candidate has been redesigned to compete against licensed mRNA-based vaccines.
The FDA approved Rhythm Pharmaceutical’s Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome.
The trial evaluated crenezumab’s ability to slow Alzheimer’s disease in cognitively unimpaired people with a specific gene mutation that causes early-onset Alzheimer’s disease.
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