Browsing Tag
US FDA
379 posts
FDA approves Iovance’s AMTAGVI: A breakthrough in melanoma treatment
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a trailblazer in the field of biotechnology focused on developing novel polyclonal tumor…
Kurome Therapeutics advances with FDA-approved IND for KME-0584 in AML and HR MDS clinical trial
In a significant development for cancer research, Kurome Therapeutics Inc. has announced the U.S. Food and Drug Administration…
FDA advances Sarepta Therapeutics’ ELEVIDYS for Duchenne muscular dystrophy treatment
In a promising development for the treatment of rare diseases, Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a frontrunner in precision…
FDA grants Otsuka’s Sibeprenlimab breakthrough therapy designation in IgAN
In a significant development for the treatment of kidney disease, the U.S. Food and Drug Administration (FDA) has…
FDA approves Genentech’s Xolair for food allergies: A new horizon in allergy treatment
The U.S. Food and Drug Administration (FDA) has approved Xolair (omalizumab) for reducing allergic reactions, including anaphylaxis, that…
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…
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…
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…
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)…
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…