FDA
EndoCyclic New Drug application approved by US FDA for endometriosis treatment
March 24, 2026Research and Development EndoCyclic Therapeutics, FDA, endometriosis
EndoCyclic Therapeutics’ Investigational New Drug (IND) application for its lead programme, ENDO-205, has been approved by the US FDA. With …
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
January 27, 2026FDA, 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 …
Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
January 22, 2026Research 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), …
Johnson & Johnson submits robotic surgical system for De Novo classification
January 8, 2026Research 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 …
MedPharm announces US FDA inspection of North Carolina manufacturing facility
January 6, 2026Manufacturing and Production FDA, MedPharm
MedPharm has announced that the US Food and Drug Administration (FDA) has completed a successful inspection of its topical drug …
Rethinking oncology trial endpoints with generalised pairwise comparisons
November 4, 2025Research 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) …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
October 14, 2025Alto Neuroscience, FDA, schizophrenia
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) has received Fast Track designation …
FDA approves Moderna’s updated COVID-19 vaccines targeting new variant
September 1, 2025FDA
The US Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 vaccines, Spikevax and mNEXSPIKE, intended to target the …
FDA approves Gamifant for macrophage activation syndrome in Still’s disease
June 30, 2025Medical 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 …
FDA grants orphan drug designation to antibody-mediated rejection treatment
June 26, 2025Research 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 …
FDA approves Incyte’s new anal cancer treatment
May 20, 2025Research 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 …
FDA approves diagnostic tool for MET-targeted lung cancer therapy
May 19, 2025Research 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 …
Medable unveils oncology trial platform aimed at reducing logistical hurdles
May 16, 2025Biotech/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 …
Moleculin secures EMA approval to expand acute myeloid leukaemia trial across EU
May 16, 2025Research 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 …
Kaerus Bioscience secures FDA approval for rare genetic disorder treatment
May 15, 2025Research 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 …
