Tag: US FDA
FDA clears Bone Solutions magnesium-based bone substitute for spinal surgery
Bone Solutions Inc., an innovative orthobiologics technology company based in Colleyville, Texas, has achieved a milestone with the 510(k) clearance of Mg OSTEOCRETE from the ... Read More
GSK advances in Hepatitis B cure with FDA’s fast track for bepirovirsen
In a significant development for the treatment of chronic hepatitis B (CHB), GSK plc (LSE/NYSE: GSK) has announced that the US Food and Drug Administration ... Read More
Samsung Health Monitor app gains FDA approval for sleep apnea feature
Samsung Electronics has made significant strides in health technology, with its Samsung Health Monitor app receiving De Novo authorization from the U.S. Food and Drug ... Read More
Hemogenyx Pharmaceuticals receives FDA nod for HEMO-CAR-T AML treatment study
Hemogenyx Pharmaceuticals plc, a London-based biopharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) to proceed with its Phase I clinical ... Read More
Lupin Limited secures FDA approval for generic Bromfenac Ophthalmic Solution
In a significant development for the global pharmaceutical industry, Lupin Limited (Lupin) has announced its latest achievement: receiving approval from the United States Food and ... Read More
Strides Pharma Science receives FDA approval for Pregabalin capsules
Strides Pharma Science Limited (Strides) has achieved a significant milestone in the pharmaceutical industry with the United States Food & Drug Administration (USFDA) approval of ... Read More
FDA approves Merck’s KEYTRUDA for advanced cervical cancer treatment
Merck, known as MSD outside of the United States and Canada, has received approval from the U.S. Food and Drug Administration (FDA) for KEYTRUDA, its ... Read More
Drug Farm’s DF-003 gets FDA rare pediatric disease designation for ROSAH Syndrome
Drug Farm, a clinical-stage biopharmaceutical company, has announced that its alpha-kinase 1 (ALPK1) inhibitor, DF-003, has been granted Rare Pediatric Disease (RPD) Designation by the ... Read More
Nuvation Bio receives FDA clearance for NUV-1511 IND in advanced solid tumors
In a significant stride for cancer treatment, Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company dedicated to addressing unmet needs in oncology, announced the U.S. ... Read More
AstraZeneca, Ionis Pharmaceuticals get FDA approval of Wainua for ATTRv-PN
In a major development for hereditary transthyretin-mediated amyloidosis (ATTRv-PN or hATTR-PN) patients, the US Food and Drug Administration (FDA) has approved Wainua (eplontersen), developed by ... Read More