Browsing Tag
US Food and Drug Administration
333 posts
Foamix Pharmaceuticals bags AMZEEQ FDA approval for moderate to severe acne
AMZEEQ FDA approval : Israeli specialty pharma company Foamix Pharmaceuticals has bagged approval from the US Food and…
Janssen bags Xarelto FDA approval to prevent blood clots in acutely ill patients
Xarelto FDA approval : The Janssen Pharmaceutical Companies of Johnson & Johnson has secured approval from the US…
Denovo Biopharma gets FDA approval to launch phase 2b GBM trial for DB102
Denovo Biopharma has secured approval from the US Food and Drug Administration (FDA) to launch its phase 2b…
Lilly bags Reyvow FDA approval for acute treatment of migraine
Reyvow FDA approval : Eli Lilly and Company (Lilly) has bagged approval from the US Food and Drug…
Novartis bags Beovu FDA approval for wet AMD
Beovu FDA approval for wet AMD : Swiss pharma giant Novartis has been given approval from the US…
ProTom Radiance 330 proton therapy system bags FDA 510(k) Clearance
ProTom International has been given 510(k) clearance from the US Food and Drug Administration (FDA) for its Radiance…
Verastem gets FDA orphan drug status for COPIKTRA for T-Cell lymphoma
Verastem Oncology has secured orphan drug designation for COPIKTRA (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K), from…
Sound Pharmaceuticals bags FDA fast track status for SPI-1005 in Meniere’s Disease
US biopharma company Sound Pharmaceuticals said that its investigational drug SPI-1005 has secured the fast track designation (FTD)…
Dynacure’s centronuclear myopathies drug DYN101 gets FDA orphan drug designation
French pharma company Dynacure has secured orphan drug designation for its investigational antisense drug DYN101 from the US…
Stokes’ STK-001 secures FDA orphan drug designation for Dravet Syndrome
US biotech company Stoke Therapeutics has secured orphan drug designation for its lead product candidate – STK-001 from…