Phase 1/2a clinical trial currently supported by a $3.0 million grant from the U.S. Department of Defense Trial will enroll ...

The Axiom-4 mission will be carrying 'Rebecsinib', the first cancer drug with active US FDA 'Investigational New Drug' (IND) ...

The program will bring together experts from across the FDA for a team-based review, rather than having an application move ...

Aldeyra has resubmitted its new drug application for reproxalap, an investigational dry eye treatment, which contained new ...

The OCU410ST Phase 2/3 pivotal confirmatory trial represents a major advancement as Ocugen's second late-stage clinical program. Ocugen plans to submit a BLA for OCU410ST in 2027 in alignment with its ...

The U.S. Food and Drug Administration (FDA) on Tuesday announced it is launching a voucher program to accelerate reviews of ...

YolTech Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for YOLT-101, an In Vivo Base Editing Therapy to Treat Heterozygous Familial Hypercholesterolemia (HeFH) ...

The Inflation Reduction Act includes an exemption for orphan drugs for a single indication, but experts say this is far from ...

Rebel Medicine Announces Series A Financing and Investigational New Drug (IND) Application Opening to Advance Non‑Opioid Pain Therapeutic into Clinical Development By Rebel Medicine Inc Jun 12, 2025 ...

Most in a small group of patients receiving a stem cell-based infusion no longer needed insulin, but the drug may not suit ...