FDA rejects Alkermes’ depressive disorder drug
The US Food and Drug Administration (FDA) has rejected Alkermes’ filing for ALKS 5461 in major depressive disorder (MDD), asking for more clinical data.
Read More
Tag: ALKS 5461
FDA advisors turn down Alkermes’ ALKS 5461
Alkermes’ ALKS 5461 has been hit with a potential setback in the US after regulatory advisors failed to back its approval for major depressive disorder (MDD).
Read More
Alkermes boosted by trial success for antidepressant
Shares in Ireland-headquartered Alkermes shot up nearly 50 percent after its experimental depression drug hit targets in a pivotal late-stage trial.
Read More
- Bioxytran reports positive phase 1b/2a results for antiviral ProLectin‑M
- FDA approves once‑weekly Sogroya for wider paediatric use
- SolasCure trial shows faster healing with Aurase Wound Gel
- Gilead data show investigational HIV combination maintains viral suppression
- Verdiva Bio completes enrolment for phase 2b study of oral GLP‑1 candidate VRB‑101
