Healio

FDA clears investigational new drug application for ER-100

Life Biosciences plans to begin human clinical trials of a cellular rejuvenation therapy in optic neuropathies after ...

Unicycive granted FDA review for resubmitted marketing application for kidney disease drug

Unicycive Therapeutics (UNCY) announced on Thursday that the U.S. Food and Drug Administration (FDA) has accepted its ...

Elevar Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for Rivoceranib in Combination with Camrelizumab as a First-line Systemic Treatment for ...

Elevar Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for Rivoceranib in Combination with Camrelizumab as a First-line Systemic Treatment for Unresectable Hepatocellular ...
JD Supra

(Update) FDA releasing CRLs for unapproved drugs and biologics, including applications not previously publicly disclosed or acknowledged

FDA's release of CRLs for unapproved products does not appear to be limited to situations where the application's existence had been publicly disclosed or acknowledged. Based on our review of those ...
Healio

FDA clears investigational new drug application for NOV05

The FDA cleared an investigational new drug application to advance NOV05 in a phase 2 clinical trial in noninfectious ...
Ophthalmology Times

FDA clears Novaliq’s Investigational New Drug application for NOV05

The US Food and Drug Administration (FDA) has cleared Novaliq’s Investigational New Drug (IND) application for NOV05, enabling the initiation of the EYETAC phase II clinical trial ( NCT07285070) in ...