Tag: US FDA
FDA approves first drug for advanced MASH, Rezdiffra
by Editor | Mar 18, 2024 | LATEST NEWS, Pharmaceuticals & Manufacturing, WORLD NEWS | 0
USA—Rezdiffra has been approved by the Food and Drug Administration, marking a significant...
Read MoreKenya’s Pharmacy and Poisons Board strengthens medical device regulation with US FDA collaboration
by Editor | Mar 18, 2024 | AFRICAN & MIDDLE EAST NEWS, Government, Regulatory & Policy News, LATEST NEWS, Magazine Issues | 0
USA—The Pharmacy and Poisons Board (PPB) has achieved a significant milestone in regulatory...
Read MoreQBiotics wins FDA orphan status for rainforest-derived cancer drug
by Editor | Feb 19, 2024 | LATEST NEWS, WORLD NEWS | 0
– Australian biotech QBiotics has won an orphan drug designation for a drug based on a chemical obtained from the blushwood tree, which is being investigated as a treatment for a rare group of cancers called soft tissue sarcoma.
Read MoreBayer scores Japan approval for Eylea injection 8 mg for treatment of wet nAMD, DME
by Editor | Jan 22, 2024 | Government, Regulatory & Policy News, LATEST NEWS, Pharmaceuticals & Manufacturing, WORLD NEWS | 0
JAPAN – The Japanese Ministry of Health, Labour and Welfare has granted marketing authorization in...
Read MoreNovartis to start pharmaceutical production of Pluvicto in the US
by Editor | Jan 12, 2024 | LATEST NEWS, Pharmaceuticals & Manufacturing, WORLD NEWS | 0
SWITZERLAND – Novartis plans to start commercial production of Pluvicto at its large-scale,...
Read MoreFDA approves US WorldMeds’ breakthrough oral drug Iwilfin for high-risk neuroblastoma maintenance therapy
by Editor | Dec 18, 2023 | Government, Regulatory & Policy News, LATEST NEWS, Pharmaceuticals & Manufacturing, WORLD NEWS | 0
USA — The FDA has approved US WorldMeds’ oral drug eflornithine, now branded as Iwilfin,...
Read MoreFDA greenlights Lyrus’ prescription drug for complicated urinary tract infections
by Editor | Dec 15, 2023 | LATEST NEWS, Pharmaceuticals & Manufacturing, WORLD NEWS | 0
INDIA – Lyrus Life Sciences has earned approval from the U.S. Food and Drug Administration (FDA)...
Read MoreMedtronic’s PulseSelect Pulsed Field Ablation System wins FDA approval
by Editor | Dec 14, 2023 | Government, Regulatory & Policy News, LATEST NEWS, Medical Devices & Innovations, WORLD NEWS | 0
USA — The US FDA has granted approval to Medtronic for its PulseSelect Pulsed Field Ablation (PFA)...
Read MoreUS FDA greenlights historic CRISPR-based gene therapies for Sickle Cell Disease
by Editor | Dec 10, 2023 | Government, Regulatory & Policy News, LATEST NEWS, Pharmaceuticals & Manufacturing, WORLD NEWS | 0
USA – The US Food and Drug Administration (FDA) has granted approval for the groundbreaking...
Read MoreHuma’s disease management platform nabs Saudi FDA Class C certification
by Editor | Dec 7, 2023 | AFRICAN & MIDDLE EAST NEWS, Government, Regulatory & Policy News, LATEST NEWS, Medical Devices & Innovations | 0
SAUDI ARABIA – Global digital health firm Huma Therapeutics has been granted multi-condition Saudi...
Read MoreFDA approves Novartis’ Fabhalta, a groundbreaking oral monotherapy for rare blood disease treatment
by Editor | Dec 7, 2023 | Government, Regulatory & Policy News, LATEST NEWS, Pharmaceuticals & Manufacturing, WORLD NEWS | 0
SWITZERLAND — The U.S. Food and Drug Administration (FDA) has approved Novartis’ oral drug...
Read MoreJanet Woodcock, a long-time FDA official to retire in 2024 after 37 years
by Editor | Nov 22, 2023 | LATEST NEWS, People News, WORLD NEWS | 0
USA — Janet Woodcock, a distinguished figure at the Food and Drug Administration (FDA) and a...
Read More