Browsing Tag
US FDA
379 posts
FDA approves Agios Pharmaceuticals’ TIBSOVO for acute myeloid leukemia
The US Food and Drug Administration (FDA) has granted approval to Agios Pharmaceuticals’ TIBSOVO (ivosidenib) for the treatment…
FDA advisory committee endorses GSK’s malaria drug tafenoquine
The Antimicrobial Drugs Advisory Committee (AMDAC) of the United States Food and Drug Administration (FDA) has given a…
Amgen and UCB resubmit BLA for EVENITY to transform osteoporosis treatment in postmenopausal women
Amgen, in collaboration with UCB, has announced the resubmission of the biologics license application (BLA) for their osteoporosis…
FDA sets review date for Ironshore Pharmaceuticals’ ADHD drug HLD200
Ironshore Pharmaceuticals & Development, a subsidiary of Highland Therapeutics, has reached a significant milestone with the U.S. Food…
FDA removes clinical hold on Advaxis’ Axalimogene Filolisbac, Durvalumab combo trial
Advaxis, a biotech firm based in New Jersey, announced a significant regulatory update as the U.S. Food and…
Siga Technologies secures Tecovirimat FDA approval for smallpox treatment
Siga Technologies has achieved a significant milestone with the U.S. Food and Drug Administration’s (FDA) approval of its…
Astellas, Pfizer bag Xtandi FDA approval for non-metastatic CRPC
In a significant development, Astellas Pharma and Pfizer have announced that the U.S. Food and Drug Administration (FDA)…
Mylan launches generic Estradiol Vaginal Cream after securing FDA approval
Mylan, a global pharmaceutical company, has recently announced the U.S. Food and Drug Administration (FDA) approval of its…
FDA approves ViiV Healthcare’s Juluca for maintenance treatment of HIV-1
ViiV Healthcare, a joint venture between GlaxoSmithKline (GSK), Pfizer, and Shionogi, has received approval from the U.S. Food…
FDA grants accelerated approval to AstraZeneca’s Calquence for mantle cell lymphoma treatment
AstraZeneca has achieved a significant milestone with the early FDA approval of Calquence (acalabrutinib) for the treatment of…