Rachel Hartley, Author at Pharma Globenewswire

Imviva Biotech Receives FDA Orphan Drug Designation

FDA Grants Orphan Drug Designation to CTD402, an Off‑the‑Shelf Anti‑CD7 CAR‑T Therapy, for Rare T‑Cell Leukemias and Lymphomas

The Food and Drug Administration (FDA) has granted orphan drug designation to CTD402, an investigational allogeneic anti‑CD7 CAR‑T cell therapy from Imviva Biotech, for the treatment of patients with relapsed or refractory T‑cell acute lymphoblastic leukemia (T‑ALL) and lymphoblastic lymphoma (T‑LBL). This

6 February 2026

Clinical Trials

Shilpa Medicare’s Biologicals Unit Secures FDA Orphan Drug Designation for Investigational Monoclonal Antibody Targeting Rare Blood Cancers

Shilpa Biologicals Private Limited, a wholly-owned subsidiary of Shilpa Medicare Limited, in collaboration with Switzerland-based mAbTree Biologics AG, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to their investigational biologic product. The designation covers a

5 February 2026

Clinical Trials

FDA Grants Breakthrough Therapy Designation to Bezuclastinib Plus Sutent for Advanced GIST After GLEEVEC Failure

The Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to bezuclastinib in combination with Sutent (sunitinib) for adults with advanced gastrointestinal stromal tumors (GIST) whose disease has progressed on, or become resistant to, GLEEVEC (imatinib), according to a recent update

5 February 2026

Clinical Trials

The FDA Grants Fast Track Designation to Novel GPRC5D/CD3 Bispecific Antibody LBL‑034 for Relapsed/Refractory Multiple Myeloma

The Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to LBL‑034, an investigational GPRC5D/CD3 bispecific T‑cell engager, for the treatment of patients with relapsed or refractory multiple myeloma. The designation is based on encouraging safety, efficacy, and durability signals

4 February 2026

Clinical Trials

Quetzal Therapeutics’ QTX-2101 Secures FDA Fast Track Designation for the Treatment of Acute Promyelocytic Leukemia

Quetzal Therapeutics, a biopharmaceutical company focused on developing treatments for rare diseases, today announced that the Food and Drug Administration (FDA) has granted Fast Track designation to QTX-2101, the company’s investigational oral arsenic trioxide capsule, for the treatment of patients with acute

3 February 2026

Uncategorised

Biogen’s Litifilimab Receives FDA Breakthrough Therapy Designation for Cutaneous Lupus Erythematosus: A First-in-Class BDCA2 Targeting Therapy

The Food and Drug Administration (FDA) has granted breakthrough therapy designation to litifilimab (BIIB059), a humanized monoclonal antibody developed by Biogen, for the treatment of cutaneous lupus erythematosus (CLE). This regulatory milestone represents a significant advancement for patients living with an orphan

2 February 2026

Clinical Trials

FDA Grants Ipsen’s IPN60340 Breakthrough Therapy Designation for First-Line Treatment of Elderly Patients with Acute Myeloid Leukemia

The Food and Drug Administration (FDA) has awarded Breakthrough Therapy Designation to IPN60340 (ICT01), Ipsen’s investigational anti-BTN3A monoclonal antibody, in combination with venetoclax and azacitidine for first-line treatment of acute myeloid leukemia (AML) in patients ineligible for intensive chemotherapy. This regulatory acceleration

2 February 2026

Drug Launches & Approvals

FDA Approves Agios’ AQVESME (mitapivat) as First Oral Therapy for Thalassemia: A Watershed Moment for Anemia Management

The Food and Drug Administration (FDA) has granted approval to AQVESME (mitapivat), marking a historic milestone in the thalassemia treatment. As the first oral therapy indicated for adults with both non-transfusion-dependent (NTD) and transfusion-dependent (TD) alpha- or beta-thalassemia, this approval represents a

21 January 2026

Clinical Trials

Novartis Ianalumab Receives FDA Breakthrough Therapy Designation for Sjögren’s Disease: First Targeted BAFF-R Blocking B-Cell Depleter Demonstrates Statistically Significant Disease Activity Reduction; Regulatory Submissions Planned Q1 2026

NEPTUNUS-1 and NEPTUNUS-2 met primary endpoints with clinically meaningful improvements in ESSDAI and patient-reported outcomes across 779 globally enrolled patients; ianalumab positioned to become first approved targeted treatment for second most prevalent rheumatic autoimmune disease Novartis announced that the U.S. Food and

16 January 2026

Drug Launches & Approvals

FDA Approves Johnson & Johnson’s DARZALEX FASPRO (Daratumumab and Hyaluronidase-fihj) for High-Risk Smoldering Multiple Myeloma: Advancing Early Multiple Myeloma Intervention

The multiple myeloma therapeutic landscape has undergone a significant transformation with the FDA’s approval of Johnson & Johnson (NYSE:JNJ)’s DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM). This regulatory milestone, announced on November

28 November 2025

Rachel Hartley

FDA Grants Orphan Drug Designation to CTD402, an Off‑the‑Shelf Anti‑CD7 CAR‑T Therapy, for Rare T‑Cell Leukemias and Lymphomas

Shilpa Medicare’s Biologicals Unit Secures FDA Orphan Drug Designation for Investigational Monoclonal Antibody Targeting Rare Blood Cancers

FDA Grants Breakthrough Therapy Designation to Bezuclastinib Plus Sutent for Advanced GIST After GLEEVEC Failure

The FDA Grants Fast Track Designation to Novel GPRC5D/CD3 Bispecific Antibody LBL‑034 for Relapsed/Refractory Multiple Myeloma

Quetzal Therapeutics’ QTX-2101 Secures FDA Fast Track Designation for the Treatment of Acute Promyelocytic Leukemia

Biogen’s Litifilimab Receives FDA Breakthrough Therapy Designation for Cutaneous Lupus Erythematosus: A First-in-Class BDCA2 Targeting Therapy

FDA Grants Ipsen’s IPN60340 Breakthrough Therapy Designation for First-Line Treatment of Elderly Patients with Acute Myeloid Leukemia

FDA Approves Agios’ AQVESME (mitapivat) as First Oral Therapy for Thalassemia: A Watershed Moment for Anemia Management

Novartis Ianalumab Receives FDA Breakthrough Therapy Designation for Sjögren’s Disease: First Targeted BAFF-R Blocking B-Cell Depleter Demonstrates Statistically Significant Disease Activity Reduction; Regulatory Submissions Planned Q1 2026

FDA Approves Johnson & Johnson’s DARZALEX FASPRO (Daratumumab and Hyaluronidase-fihj) for High-Risk Smoldering Multiple Myeloma: Advancing Early Multiple Myeloma Intervention

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