CLN-049, a Novel FLT3xCD3 T Cell Engager, in Relapsed/Refractory Acute Myeloid Leukemia
Phase 1
Orphan Drug Designation
05/19/2026
05/19/2026
Cullinan Therapeutics Receives FDA Orphan Drug Designation for CLN-049, a Novel FLT3xCD3 T Cell Engager, in Relapsed/Refractory Acute Myeloid Leukemia
09/05/2025
CERO
CERo Therapeutics Holdings
08:00 AM
FDA Decision
CER-1236
For the treatment of Acute Myeloid Leukemia (AML)
Phase 2
Fast Track Designation
09/05/2025
09/05/2025
09/04/2025
AMRX
Amneal Pharmaceuticals
04:01 PM
FDA Decision
Risperdal Consta
An extended-release injectable suspension 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial and 50 mg/vial,
Approved
FDA Approval
09/04/2025
09/04/2025
09/04/2025
LLY
Eli Lilly and Company
07:45 AM
FDA Decision
Olomorasib + KEYTRUDA (pembrolizumab)
For the first-line treatment of patients with unresectable advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation and PD-L1 expression = 50%
SUNRAY-01 Phase 3
Breakthrough Therapy designation
09/04/2025
09/04/2025
07/02/2025
TIL
Instil Bio
06:00 AM
FDA Decision
AXN-2510
A PD-L1xVEGF Bispecific Antibody, for the treatment of Relapsed/Refractory Solid Tumors
Phase 1
Investigational New Drug (IND)
11/30/-0001
11/30/-0001
Instil Bio, Inc. (TIL) announced that the U.S. Food and Drug Administration has cleared an Investigational New Drug (IND) application for AXN-2510. Instil Bio plans to initiate a phase 1 trial of 2510 as monotherapy for patients with relapsed/refractory solid tumors before the end of 2025. The trial is designed to evaluate the safety of 2510 in patients with solid tumors. It also aims to assess the efficacy of the treatment. Additionally, the study will examine the pharmacokinetics and pharmacodynamics of the drug.
07/02/2025
REGN
Regeneron Pharmaceuticals
11:00 AM
FDA Decision
Lynozyfic™ (linvoseltamab-gcpt)
To treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody.
Approved
FDA Accelerated Approval
11/30/-0001
11/30/-0001
Regeneron Pharmaceuticals, Inc. (REGN) announced that the U.S. Food and Drug Administration has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. These therapies include a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody. Lynozyfic was granted accelerated approval based on response rate and durability of response in the LINKER-MM1 trial.
Intravenous or Subcutaneous Use in People Aged Two and Older with Primary Immunodeficiency
Approved
FDA Approval
11/30/-0001
11/30/-0001
Takeda (TAK) announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC immune globulin infusion (human) with less than or equal to 2 µg/mL IgA in a 10% solution. It is the only ready-to-use liquid immunoglobulin therapy with low immunoglobulin A content. The therapy is approved as a replacement treatment for people two years of age and older with primary immunodeficiency.
