Pharma Globenewswire

Sickle Cell Disease Market Set for Robust Expansion at a CAGR of 22.1% (2025–2034) Across 6MM, Driven by Rising Prevalence and Breakthrough Gene Therapies

20 January 2026

The Sickle Cell Disease (SCD) market is projected to experience remarkable growth through 2034, supported by increasing disease prevalence, improving diagnostic awareness, and rapid advancements in disease-modifying and gene-based therapies. According to DelveInsight, the market is expected to expand at a CAGR

Clinical Trials

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

20 January 2026

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

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

16 January 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

Clinical Trials

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

16 January 2026

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

Drug Launches & Approvals

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

15 January 2026

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

Clinical Trials

Encoded Therapeutics Achieves Breakthrough Status for ETX101, Advancing Gene Therapy for Dravet Syndrome

13 January 2026

Encoded Therapeutics, a clinical-stage biotechnology company focused on precision genetic medicines for severe neurological disorders, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ETX101 for the treatment of SCN1A+ Dravet syndrome. The designation represents a

Clinical Trials

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

12 January 2026

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

Artificial Intelligence

Philips Advances Cardiac MR with AI-Powered Innovations: Expanding Access and Enhancing Diagnostic Precision

3 December 2025

Philips has announced a groundbreaking suite of AI-enabled Cardiac MR (CMR) innovations designed to transform cardiac imaging by making it faster, easier, and more accessible for both clinicians and patients. To be unveiled at RSNA 2025 in Chicago (November 30 – December

Clinical Trials

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

1 December 2025

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

Latest

Sickle Cell Disease Market Set for Robust Expansion at a CAGR of 22.1% (2025–2034) Across 6MM, Driven by Rising Prevalence and Breakthrough Gene Therapies

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

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

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

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

Encoded Therapeutics Achieves Breakthrough Status for ETX101, Advancing Gene Therapy for Dravet Syndrome

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

Philips Advances Cardiac MR with AI-Powered Innovations: Expanding Access and Enhancing Diagnostic Precision

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

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