David Langley, Author at Pharma Globenewswire

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

Corvus Pharmaceuticals Reports Robust Phase 1 Cohort 4 Data for Soquelitinib in Atopic Dermatitis

Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company pioneering interleukin-2-inducible T-cell kinase (ITK) inhibition as a novel immunotherapy platform, announced today positive results from Cohort 4 of its randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate

21 January 2026

Clinical Trials

Lantern Pharma’s LP-284 Achieves Third FDA Orphan Drug Designation for Soft Tissue Sarcomas

Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage artificial intelligence-driven biopharmaceutical company pioneering synthetic lethal approaches to oncology, announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to LP-284 for the treatment of soft tissue sarcomas. This marks

20 January 2026

Clinical Trials

GSK’s Bepirovirsen Demonstrates Statistically Significant Functional Cure Rates in Chronic Hepatitis B

GlaxoSmithKline plc announced positive results from the B-Well 1 and B-Well 2 pivotal Phase III clinical trials evaluating bepirovirsen (GSK3228836), an investigational antisense oligonucleotide (ASO) designed as the first-in-class finite-duration therapy capable of achieving functional cure in patients with chronic hepatitis B

16 January 2026

Drug Launches & Approvals

FDA Approves ZYCUBO (Copper Histidinate): First-Ever Treatment for Menkes Disease

Sentynl Therapeutics, a US-based biopharmaceutical subsidiary of Zydus Lifesciences Limited, has achieved a landmark regulatory milestone with FDA approval of ZYCUBO (copper histidinate) injection for the treatment of pediatric patients with Menkes disease. This marks the first and only FDA-approved therapy for

15 January 2026

Clinical Trials

FDA Grants Breakthrough Therapy Designation to Oculis’ PRIVOSEGTOR for Optic Neuritis: The First Neuroprotective Treatment in Rare Vision-Threatening Condition

Swiss biotech company, Oculis Holding, achieves significant regulatory milestone following successful Phase 2 ACUITY trial results; global pivotal trials underway for first-in-class therapy addressing critical unmet medical need Oculis Holding AG announced that the Food and Drug Administration (FDA) has granted Breakthrough

12 January 2026

Clinical Trials

Genprex Adds New Clinical Trial Site for Acclaim-1 and Acclaim-3 Lung Cancer Studies

Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company advancing innovative treatments for cancer and diabetes, announced that Gabrail Cancer Center in Canton, Ohio has been added as a new site for its Acclaim-1 and Acclaim-3 clinical trials evaluating the company’s lead

1 December 2025

Clinical Trials

Soligenix Hits Key Enrollment Milestone in Phase 3 Trial for HyBryte™ in Cutaneous T-Cell Lymphoma

Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company dedicated to developing and commercializing therapies for rare diseases with high unmet needs, announced the completion of the targeted enrollment of 50 patients required for the planned interim analysis in its 80-patient confirmatory Phase

1 December 2025

Drug Launches & Approvals

Strong Interim Results from Protara’s TARA‑002 in Pediatric Lymphatic Malformations

Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer and rare diseases, has announced encouraging interim findings from its ongoing Phase 2 open-label STARBORN-1 trial. The study evaluates the intracystic administration of TARA-002, the company’s

1 December 2025

Drug Launches & Approvals

POHERDY Gains FDA Approval: A New Biosimilar for HER2‑Positive Breast Cancer

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) have announced that the U.S. FDA has approved the Biologics License Application (BLA) for POHERDY® (pertuzumab‑dpzb) 420 mg/14 mL injection for intravenous administration. This interchangeable biosimilar to PERJETA (pertuzumab) is approved for all

1 December 2025

David Langley

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

Corvus Pharmaceuticals Reports Robust Phase 1 Cohort 4 Data for Soquelitinib in Atopic Dermatitis

Lantern Pharma’s LP-284 Achieves Third FDA Orphan Drug Designation for Soft Tissue Sarcomas

GSK’s Bepirovirsen Demonstrates Statistically Significant Functional Cure Rates in Chronic Hepatitis B

FDA Approves ZYCUBO (Copper Histidinate): First-Ever Treatment for Menkes Disease

FDA Grants Breakthrough Therapy Designation to Oculis’ PRIVOSEGTOR for Optic Neuritis: The First Neuroprotective Treatment in Rare Vision-Threatening Condition

Genprex Adds New Clinical Trial Site for Acclaim-1 and Acclaim-3 Lung Cancer Studies

Soligenix Hits Key Enrollment Milestone in Phase 3 Trial for HyBryte™ in Cutaneous T-Cell Lymphoma

Strong Interim Results from Protara’s TARA‑002 in Pediatric Lymphatic Malformations

POHERDY Gains FDA Approval: A New Biosimilar for HER2‑Positive Breast Cancer

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