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Showing 15 posts of 1444 posts found.

MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance

January 27, 2026
FDA, Gastrointestinal tract, MRM Health, ulcerative colitis

Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational New Drug (IND) clearance from …

News

Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation

January 22, 2026
Research and Development Complement Therapeutics, FDA, Opthalmology, geographic atrophy

Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD), …

News

Johnson & Johnson submits robotic surgical system for De Novo classification

January 8, 2026
Research and Development FDA, Gastrointestinal tract, Johnson & Johnson

Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De Novo classification from the US …

News

MedPharm announces US FDA inspection of North Carolina manufacturing facility

January 6, 2026
Manufacturing and Production FDA, MedPharm

MedPharm has announced that the US Food and Drug Administration (FDA) has completed a successful inspection of its topical drug …

News

Rethinking oncology trial endpoints with generalised pairwise comparisons

November 4, 2025
Research and Development EMA, FDA, Oncology, One2Treat, clinical trials, generalised pairwise comparisons, net treatment benefit, oncology

For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival (OS) and progression-free survival (PFS) …

Feature
brain_anatomy_medical_head_skull_digital_3_d_x_ray_xray_psychedelic_3720x2631_1

Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation

October 14, 2025
Alto Neuroscience, FDA, schizophrenia

Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) has received Fast Track designation …

News
FDA approves Moderna’s updated COVID-19 vaccines targeting new variant

FDA approves Moderna’s updated COVID-19 vaccines targeting new variant

September 1, 2025
FDA

The US Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 vaccines, Spikevax and mNEXSPIKE, intended to target the …

News
hospital_ward

FDA approves Gamifant for macrophage activation syndrome in Still’s disease

June 30, 2025
Medical Communications, Research and Development FDA, Immunology, Still's disease, gamifant, hemophagocytic lymphohistiocytosis, sobi

The US Food and Drug Administration (FDA) has approved Gamifant (emapalumab-lzsg) for the treatment of macrophage activation syndrome (MAS) in …

News
Photo of patient

FDA grants orphan drug designation to antibody-mediated rejection treatment

June 26, 2025
Research and Development FDA, Immunology, Orphan Drug Designation, Sanofi, antibody-mediated rejection, clinical trials, immunology, inflammation, organ transplantation

Sanofi has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to riliprubart for …

News

FDA approves Incyte’s new anal cancer treatment

May 20, 2025
Research and Development FDA, Incyte Corporation, Oncology, Orphan Drug Designation (ODD), Zynyz, fast track designation, priority review

The US Food and Drug Administration (FDA) has approved Incyte Corporation’s immunotherapy retifanlimab-dlwr (Zynyz) in combination with carboplatin and paclitaxel to treat …

News

FDA approves diagnostic tool for MET-targeted lung cancer therapy

May 19, 2025
Research and Development FDA, Oncology, Roche, lung cancer, non-squamous non-small cell lung cancer

The US Food and Drug Administration (FDA) has approved Roche’s VENTANA MET (SP44) RxDx Assay as a diagnostic tool to …

News

Medable unveils oncology trial platform aimed at reducing logistical hurdles

May 16, 2025
Biotech/start-up, Business Services, Research and Development, Sales and Marketing, Technical Consultancy AI, FDA, Medable, Oncology, digital platform, oncology research, oncology trials

Clinical trial technology provider, Medable, has launched a digital platform designed to support oncology clinical trials by addressing growing operational …

News
researchers

Moleculin secures EMA approval to expand acute myeloid leukaemia trial across EU

May 16, 2025
Research and Development Clinical Trial Application (CTA), European Union (EU), FDA, Food and Drug Administration, Moleculin Biotech, Oncology, Orphan Drug Designation (ODD), acute myeloid leukaemia

Moleculin Biotech has received approval from the European Medicines Agency (EMA) to expand its phase 3 ‘MIRACLE’ trial into nine …

News

Kaerus Bioscience secures FDA approval for rare genetic disorder treatment

May 15, 2025
Research and Development FDA, Fragile X syndrome, Kaerus Bioscience, Orphan Drug Designation (ODD), Rare Diseases, Rare Pediatric Drug Designations (RPDD), genetic syndromes

Kaerus Bioscience announces that its lead candidate KER-0193 has been granted both Orphan Drug Designation (ODD) and Rare Pediatric Drug …

News

Thermosome secures FDA Orphan Drug Designation for soft tissue sarcoma therapy

May 12, 2025
Research and Development European Medicines Agency (EMA), FDA, Oncology, Thermosome

Thermosome has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its lead candidate, THE001, …

News
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