Browsing Tag
FDA approval
131 posts
Johnson & Johnson’s TB drug SIRTURO receives full approval from FDA and EC
In a significant development for the treatment of drug-resistant tuberculosis (TB), Johnson & Johnson has announced that SIRTURO…
FDA approves Genentech’s Vabysmo prefilled syringe for eye diseases
In a significant advancement in the treatment of eye diseases, the U.S. Food and Drug Administration (FDA) has…
FDA approves Eli Lilly’s Kisunla for Alzheimer’s treatment
The U.S. Food and Drug Administration (FDA) has approved Kisunla (donanemab-azbt), an Alzheimer’s treatment developed by Eli Lilly…
Signet Therapeutics gets FDA IND approval for sigx1094 in diffuse gastric cancer
Signet Therapeutics, a pioneering biotech company, has achieved a significant milestone with the US Food and Drug Administration…
FDA approves Halozyme’s VYVGART Hytrulo for CIDP treatment
Halozyme Therapeutics, Inc. (NASDAQ: HALO) has achieved a significant milestone with the U.S. Food and Drug Administration (FDA)…
AbbVie’s SKYRIZI wins FDA approval for ulcerative colitis treatment
The U.S. Food and Drug Administration (FDA) has approved SKYRIZI (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor developed by AbbVie,…
FDA approves Amgen’s BLINCYTO for expanded use in B-ALL treatment
Amgen (NASDAQ: AMGN) has achieved a significant milestone with the recent U.S. Food and Drug Administration (FDA) approval…
FDA extends approval for GSK’s RSV vaccine, AREXVY, to adults aged 50-59 at increased risk
The U.S. Food and Drug Administration (FDA) has officially broadened the age indication for GSK plc’s (LSE/NYSE: GSK)…
FDA approves RYTELO by Geron for myelodysplastic syndromes
Geron Corporation (Nasdaq: GERN), a pioneering biopharmaceutical company focused on changing the course of blood cancer treatment, has…
Roche gains FDA approval for HPV self-collection kit to enhance cervical cancer screening
Roche has achieved a significant milestone with the FDA approval of its innovative human papillomavirus (HPV) self-collection solution,…