Browsing Tag
US Food and Drug Administration
348 posts
Cellectis begins MELANI-01 clinical trial for UCARTCS1 in multiple myeloma
Cellectis said that it has dosed the first patient in a phase 1 study – the MELANI-01 clinical…
Mirum gets FDA breakthrough therapy status for maralixibat for Alagille syndrome
Mirum Pharmaceuticals has secured the breakthrough therapy designation for maralixibat from the US Food and Drug Administration (FDA)…
Avrobio gets FDA orphan status for AVR-RD-02 in Gaucher disease
US gene therapy company Avrobio has secured orphan-drug designation for AVR-RD-02, its investigational gene therapy, for the treatment…
Janssen bags Stelara FDA approval for ulcerative colitis treatment
Stelara FDA approval for ulcerative colitis treatment : The Janssen Pharmaceutical Companies of Johnson & Johnson has bagged…
Alexion Pharmaceuticals bags Ultomiris FDA approval for atypical HUS
Ultomiris FDA approval : Alexion Pharmaceuticals has bagged approval from the US Food and Drug Administration (FDA) for…
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…