Clinical Trials Archives - 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

Autism-Spectrum-Disorder-Pipeline-Insights

Clinical Trials·Market Insights

Autism Spectrum Disorder Pipeline Insight 2025: Emerging Therapies, Clinical Trial Updates, and Regulatory Progress

The Autism Spectrum Disorder (ASD) Pipeline Insight 2025 highlights a rapidly evolving therapeutic landscape, driven by increasing disease prevalence, advances in neurodevelopmental research, and growing investment in precision medicine. According to DelveInsight, more than 18 biopharmaceutical companies are actively developing 20+ investigational

4 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

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

Clinical Trials

Atossa Therapeutics’ (Z)-Endoxifen Achieves FDA Orphan Drug Designation for Duchenne Muscular Dystrophy

Atossa Therapeutics, Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company developing innovative therapies in oncology and rare disease indications, announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) has granted Orphan Drug Designation to (Z)-endoxifen for the

21 January 2026

Clinical Trials·News·Reports

Next-Gen BTK Inhibitors Take Off! 30 Pharma Companies Ignite Clinical Momentum!

The BTK inhibitors clinical development landscape is rapidly evolving, supported by strong scientific validation and expanding therapeutic ambition. Rising incidence of B-cell malignancies, autoimmune diseases, and neurological disorders is intensifying demand for targeted therapies, positioning BTK inhibitors (BTKi) as a cornerstone of

21 January 2026

Clinical Trials

Eli Lilly’s Sofetabart Mipitecan Receives FDA Breakthrough Therapy Designation for Platinum-Resistant Ovarian Cancer

Eli Lilly and Company announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to sofetabart mipitecan (LY4170156) for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (PROC) who have previously received

21 January 2026

Clinical Trials

Global AI in Medical Diagnostics Market Set for Exceptional Growth at a CAGR of ~22% by 2032 | DelveInsight

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

Autism Spectrum Disorder Pipeline Insight 2025: Emerging Therapies, Clinical Trial Updates, and Regulatory Progress

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

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

Atossa Therapeutics’ (Z)-Endoxifen Achieves FDA Orphan Drug Designation for Duchenne Muscular Dystrophy

Next-Gen BTK Inhibitors Take Off! 30 Pharma Companies Ignite Clinical Momentum!

Eli Lilly’s Sofetabart Mipitecan Receives FDA Breakthrough Therapy Designation for Platinum-Resistant Ovarian Cancer

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