GH Research is scheduled to update on the FDA status of GH001 and outline its global Phase 3 plans for treatment-resistant ...

Swedish neurotech startup Flow Neuroscience has secured FDA approval for the first brain stimulation device for home use in ...

Welcome to Fierce Pharma's regulatory tracker for the first half of 2026. | In this tracker, Fierce Pharma is recording the ...

Corcept sought FDA approval despite finding relacorilant was statistically no better than placebo in one of two Phase III ...

The FDA has issued a complete response letter for an oral selective glucocorticoid receptor antagonist under investigation ...

Outlook Therapeutics' stock fell to a new low due to FDA rejection of its Lytenava filing for wet AMD. Efficacy evidence ...

The U.S. Food and Drug Administration (FDA) approved six new therapies in December 2025 for blood cancers, prostate cancer, ...

The US saw several new and expanded FDA indications this year. The top 5 most-read FDA approvals on AJMC.com included 4 novel ...

The US FDA has approved Mitapivat (Aqvesme), the first oral therapy for anemia in adults with alpha or beta thalassemia, ...

On August 8, 2025, the FDA granted accelerated approval to zongertinib for adult patients with unresectable or metastatic ...

The FDA appointed George Tidmarsh, MD, PhD, to be the nation's top drug official in July. The Center for Drug Evaluation and ...

After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite ...