FDA approves Deciphera’s Romvimza for rare tumour type
Tenosynovial giant cell tumours can cause pain, stiffness, swelling and movement limitations
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Tag: US Food and Drug Administration
AnX Robotica receives FDA clearance for small bowel capsule endoscopy technology
NaviCam ProScan is the first AI-assisted reading tool for gastrointestinal bleeding
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Regulators develop five principles for machine learning-enabled medical devices
The new principles will remove the regulatory burden for MLMD manufacturers
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FDA grants clearance for Endogena’s age-related macular degeneration treatment
The company will launch a clinical investigation of EA-2351 for geographic atrophy
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FDA approves Pfizer/BioNTech and Moderna’s adapted COVID-19 vaccines
The updated vaccines more closely target current circulating variants
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FDA grants Orphan Drug Designation to Faron’s bexmarilimab in AML
The ODD will offer clinical development and commercialisation benefits that will strengthen the drug programme
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Sandoz’s Tyruko biosimilar granted FDA approval to treat relapsing MS
The disease-modifying therapy is approved to treat all indications covered by Tysabri
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FDA grants ODD to Nexcella’s multiple myeloma treatment
The drug is currently being assessed in a phase 1b/2a clinical trial
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Pfizer’s maternal RSV vaccine receives FDA approval
The decision allows Abrysvo to be given to those who are 32 to 36 weeks into their pregnancy
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Roche withdraws US approval for Tecentriq in mTNBC
Metastatic triple-negative breast cancer treatment failed to meet PFS primary endpoint
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FDA approves Keytruda plus Lenvima for advanced kidney cancer
Combination treatment reduced the risk of disease progression or death by 61% versus Sutent
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US approval for Sanofi’s late-onset Pompe disease med Nexviazyme
The enzyme replacement therapy is designed to target the key mannose-6-phosphate receptor pathway
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- CERo reports encouraging early data from phase 1 trial of CER‑1236
- ENA Respiratory begins dosing in phase 2 study of INNA‑051 nasal spray
- Argo Biopharma doses first patient in phase 2b trial of BW‑20829
- Akari files new patent and advances second ADC targeting CEACAM5
- BioMed X launches kidney disease project in partnership with the government of Barbados
