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FDA
FDA Reversals in Rare Disease Space Highlight Confusion Around External Controls
While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external controls—the application of this flexibility appears to be inconsistent. One former regulator says the situation is more nuanced.
April 6, 2026
·
6 min read
·
Heather McKenzie
Press Releases
Vetter Strengthens its Global Clinical Manufacturing Network with Strategic Site Enhancements
Further advancements in Europe and the US increase capacity and process efficiency ● Construction of new clinical manufacturing facility in Des Plaines on schedule ● Established Skokie site with ongoing strong performance for biotech partners ● Infrastructure upgrades at Austrian site further streamline customers’ path to clinic
April 14, 2026
·
1 min read
Press Releases
Cardiol Therapeutics Expands U.S. MAVERIC Phase III Trial Network to Address Growing Interest in the Pivotal Program
April 28, 2026
·
8 min read
Press Releases
CAPLYTA® (lumateperone) showed greatest improvement across key efficacy outcomes among adjunctive MDD treatments in new network meta-analysis
May 4, 2026
·
17 min read
Press Releases
Randomized Controlled Trial Published in Urogynecology Demonstrates Leva® Pelvic Health System’s Efficacy in Treating Fecal Incontinence
April 17, 2026
·
6 min read
Weight loss
Novo’s Next-Gen Obesity Drug Beats Wegovy on Blood Sugar Control in Phase III
While CagriSema bested Novo Nordisk’s Wegovy on blood sugar control in a late-stage trial, the next-gen weight loss drug still has not met the pharma’s 25% weight loss goal.
February 3, 2026
·
2 min read
·
Tristan Manalac
Press Releases
NKGen Biotech Expands Clinical Trial Site Network for Alzheimer’s Disease Program Across U.S. to Improve Patient Access and Support Enrollment
May 19, 2026
·
6 min read
Press Releases
Dyno Therapeutics Announces Expanded Frontiers Network and Second Annual Genetic Agency Technology Conference (GATC)
May 14, 2026
·
7 min read
Press Releases
Photon Raises $16M Series A to Give Patients Control Over Their Prescriptions and Bring Transparency to Pharmacy
April 30, 2026
·
6 min read
Press Releases
Nexalin Announces Peer-Reviewed Publication with Neuroimaging Data in Psychotherapy and Psychosomatics Highlighting Brain-Network Effects and Clinical Improvement in Chronic Insomnia
April 28, 2026
·
9 min read
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