Pharma Globenewswire

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

Clinical Trials

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

1 December 2025

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

Drug Launches & Approvals

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

1 December 2025

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

Drug Launches & Approvals

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

1 December 2025

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

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

28 November 2025

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

Drug Launches & Approvals

FDA Approves AstraZeneca’s KOSELUGO (Selumetinib) for Adults with Neurofibromatosis Type 1 with Inoperable Plexiform Neurofibromas

28 November 2025

The pharmaceutical landscape for neurofibromatosis type 1 (NF1) treatment has reached a significant turning point with the FDA’s approval of KOSELUGO (selumetinib, AstraZeneca Pharmaceuticals LP) on November 19, 2025, for adults with NF1 who have symptomatic, inoperable plexiform neurofibromas (PN). This regulatory

Latest

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

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

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

FDA Approves AstraZeneca’s KOSELUGO (Selumetinib) for Adults with Neurofibromatosis Type 1 with Inoperable Plexiform Neurofibromas

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