CURE

FDA Application Submitted for Rusfertide Treatment in Polycythemia Vera

Takeda and Protagonist Therapeutics have submitted a new drug application to the FDA for rusfertide for adults with ...
C&EN

FDA’s new drug approvals dipped in 2025

46 new molecular entities cleared the agency’s hurdles last year, 4 fewer than in 2024 ...

Compass Pathways Announces FDA Acceptance of IND Application for PTSD and Hosts Webinar on PTSD and TRD

Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, today announced that the U.S. Food and Drug Administration (FDA) has ...

Kelonia Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for KLN-1010, an in vivo BCMA CAR-T Therapy for Relapsed and Refractory Multiple Myeloma

Kelonia Therapeutics, Inc., a clinical-stage biotechnology company pioneering in vivo gene delivery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational ...

GH Research Shares Up, Plans to Provide Update on New Drug Application

Shares of GH Research rose on plans to provide an update on the status of its investigational new drug application for GH001, a therapy for treatment-resistant depression. The stock climbed 19% to $15 ...
The Manila Times

Curium’s Investigational New Drug Application Accepted by Center for Drug Evaluation in China

Curium’s Investigational New Drug (IND) application for 177Lu-PSMA-I&T, a therapeutic agent for patients with metastatic ...
Pharmabiz

US FDA accepts Axsome Therapeutics’ supplemental New Drug Application for AXS-05 to treat Alzheimer’s disease agitation

US FDA accepts Axsome Therapeutics’ supplemental New Drug Application for AXS-05 to treat Alzheimer’s disease agitation: New York Saturday, January 3, 2026, 12:00 Hrs [IST] Ax ...
Cure Today

FDA Accepts New Drug Application for Relacorilant in Ovarian Cancer

Relacorilant targets glucocorticoid receptor proteins, potentially redefining treatment for platinum-resistant ovarian cancer by inhibiting cancer cell proliferation. Clinical trials show relacorilant ...
Pharmabiz

FibroBiologics submits IND application with US FDA to initiate clinical trials of CYPS317 in psoriasis patients

FibroBiologics submits IND application with US FDA to initiate clinical trials of CYPS317 in psoriasis patients: Houston Saturday, January 3, 2026, 11:00 Hrs [IST] FibroBiologics ...
Medscape

First New PTSD Drug in Two Decades On the Horizon?

The Psychopharmacologic Drugs Advisory Committee of the FDA is set to meet on July 18 to consider a supplemental new drug application for brexpiprazole (Rexulti, Otsuka Pharmaceutical Co., Ltd.), in ...
FiercePharma

FDA avoids the worst amid government shutdown, but new applications put on hold

With a government shutdown now in effect, the U.S. FDA—already shaken up by head count reductions earlier this year—has sought to keep many of its functions running for the foreseeable future. But the ...
Seeking Alpha

Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Corcept Therapeutics Incorporated (CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, ...