Browsing Tag
US FDA
379 posts
Synspira’s PAAG15A receives orphan drug designation for cystic fibrosis treatment
Synspira Therapeutics’ investigational inhaled treatment, PAAG15A, has been granted orphan drug designation by the U.S. Food and Drug…
FDA approves once-weekly dosing for Amgen’s Kyprolis in multiple myeloma treatment
The United States Food and Drug Administration (FDA) has granted approval for a new once-weekly dosing regimen of…
Eli Lilly’s Emgality gets FDA green light for migraine prevention
Eli Lilly and Company has secured approval from the US Food and Drug Administration (FDA) for its migraine…
Teva secures FDA approval for Ajovy injection in migraine prevention
Teva Pharmaceutical Industries has achieved a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) approving…
AstraZeneca secures FDA approval for Lumoxiti in hairy cell leukemia treatment
AstraZeneca has achieved a major regulatory milestone with the US Food and Drug Administration (FDA) approval of Lumoxiti…
AstraZeneca and Amgen secure FDA breakthrough designation for asthma drug tezepelumab
In a significant advancement for asthma treatment, AstraZeneca, in partnership with Amgen, has received the coveted breakthrough therapy…
FDA declines approval for Sunovion’s ADHD drug dasotraline, citing need for more data
In a regulatory setback, the U.S. Food and Drug Administration (FDA) has decided not to approve Sunovion Pharmaceuticals’…
Bayer secures FDA approval for hemophilia A treatment drug Jivi
In a major advancement for hemophilia A therapy, Bayer’s recombinant factor VIII (rFVIII) replacement therapy, Jivi (BAY94-9027), has…
Janssen Pharmaceutical’s IMBRUVICA and Rituximab combo wins FDA approval for waldenström’s macroglobulinemia treatment
Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has received approval from the US Food and Drug Administration…
Cantex Pharmaceuticals’ CX-01 receives FDA fast track designation in acute myeloid leukemia
Cantex Pharmaceuticals, a Florida-based biotechnology company, has achieved a significant milestone by securing Fast Track designation from the…