News and Updates by the Food and Drugs Administration (FDA)
HealthCare Global Enterprises (HCG) has teamed up with Accenture to propel advancements in cancer research and treatment by harnessing the power of cutting-edge artificial intelligence (AI), including generative AI and deep learning for multi-dimensional, patient-specific data analysis. This alliance merges […]
Gland Pharma, specializing in generic injectable pharmaceuticals, has obtained approval from the US Food and Drug Administration (FDA) for their latanoprost ophthalmic solution, 0.005% (2.5 mL Fill). The medication is deemed both bioequivalent and therapeutically comparable to the reference listed
Gland Pharma Gains US FDA Nod for Latanoprost Generic Version Read More »
Stallergenes Greer, a firm dedicated to allergen immunotherapy (AIT) solutions, has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a favorable opinion for broadening Palforzia’s existing use. This development is directed towards
EMA Panel Endorses Palforzia Indication Expansion for Toddler Peanut Allergy Treatment Read More »
BioNxt Solutions Inc., specializing in cutting-edge drug delivery technologies, has announced its latest project: a sublingual thin-film oral dissolvable film (ODF) for Semaglutide, labeled internally as BNT24005. This groundbreaking product aims to enhance the current administration techniques developed by Novo
BioNxt Solutions Unveils Sublingual Thin-Film ODF for Semaglutide Development Read More »
AAVantgarde Bio, a clinical-stage biotech firm headquartered in Italy, revealed that the US Food and Drug Administration (FDA) has awarded Orphan Drug Status to its leading initiative, AAVB-081, aimed at treating Usher Syndrome Type 1B (USH1B) retinitis pigmentosa. “Individuals with
Endo, Inc., a versatile company specializing in pharmaceuticals, has unveiled its new Adrenalin premixed bag, marking the first ever epinephrine in 0.9% sodium chloride injection that is FDA-approved and manufacturer-prepared for intravenous (IV) use. “This groundbreaking ready-to-use bag of epinephrine
Endo Launches FDA-Approved Ready-to-Use Adrenalin Premixed IV Bag in the USA Read More »
PTC Therapeutics, Inc., a globally recognized biopharmaceutical firm, has entered into a worldwide license and collaboration agreement with Novartis Pharmaceuticals Corporation, a division of Novartis AG. This partnership centers on PTC518, a program designed to innovate treatment for Huntington’s disease,
PTC and Novartis Form Global Partnership for Huntington’s Disease Treatment PTC518 Read More »
Movano Health (Nasdaq:MOVE) has announced securing FDA 510(k) approval for the pulse oximetry function within its EvieMED Ring. This clearance paves the way for Movano to explore further opportunities in health monitoring solutions, targeting applications like clinical trials, post-trial management,
Movano Gains FDA Approval for EvieMED Ring’s Pulse Oximetry Function Read More »
Nonin Medical has successfully obtained FDA 510(k) approval for its inaugural over-the-counter fingertip pulse oximeter, the TruO2 OTC. Starting this month, the device will be available for purchase on Amazon, with broader online retail availability expected soon. The FDA has
FDA Approves Nonin’s Tru02 OTC Pulse Oximeter for Consumer Use Read More »
GE HealthCare (Nasdaq:GEHC) has revealed its plans to purchase the remaining 50% interest in Nihon Medi-Physics, making it the sole owner of the Japanese radiopharmaceutical enterprise. This transaction, orchestrated with Sumitomo Chemical, is anticipated to be finalized by early 2025,
GE HealthCare Set to Acquire Full Control of Nihon Medi-Physics Read More »